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A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS

[version 1; peer review: 1 approved, 1 not approved]
Samarpan Patel
https://orcid.org/0009-0002-3076-7344
1, Aruna Chandak1, Dnyanshree Wanjari1
Samarpan Patel
https://orcid.org/0009-0002-3076-7344
1, Aruna Chandak1, Dnyanshree Wanjari1
PUBLISHED 19 Apr 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Any individual undergoing surgery is concerned about postoperative discomfort. It modifies the body’s physiological reaction and impacts an individual’s psychological state. A physician can meet early mobilization goals by effectively managing postoperative pain and preventing related co-morbidities. Targeting different phases of the pain pathway, from perception to central modulation, is successfully accomplished through the use of different drug combinations and regional anesthetic block techniques. Local anaesthetics injected intrathecally in a single injection create a superb surgical field and can even make a patient pain-free two to three hours following surgery. By adding certain adjuncts, this period can be prolonged, and there will be long-term benefits in terms of decreasing the dosage of opioid analgesics. Because of its faster start of the action and low side effects, spinal anaesthesia is the procedure most frequently used for caesarean sections. Many intrathecal additives have been explored since it has a limited role in postoperative pain control. Adjuvants such as opioids, clonidine, adrenaline, and phenylephrine have been explored recently. These chemicals have been linked to several problems, including tachycardia, respiratory depression with opioids, hypertension with adrenaline and clonidine, and excessive sedation. In this study, our primary objective is to compare the duration of postoperative analgesia between Dexamethasone and dexmedetomidine, as Dexamethasone is an anti-inflammatory drug and dexmedetomidine is an alpha-two agonist that binds with a G protein-coupled receptor. our secondary objectives include comparing intraoperative hemodynamics, intraoperative sedation, and intraoperative shivering between Dexamethasone and dexmedetomidine.

CTRI REF.NO-REF/2023/05/067283

Keywords

Cesarean section, Dexamethasone, Dexmedetomidine, Postoperative analgesia,Bupivacaine,Intraoperative haemodynamics

Corresponding authors: Samarpan Patel, Aruna Chandak, Dnyanshree Wanjari
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2024 Patel S et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Patel S, Chandak A and Wanjari D. A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS [version 1; peer review: 1 approved, 1 not approved]. F1000Research 2024, 13:300 (https://doi.org/10.12688/f1000research.144482.1) First published: 19 Apr 2024, 13:300 (https://doi.org/10.12688/f1000research.144482.1) Latest published: 19 Apr 2024, 13:300 (https://doi.org/10.12688/f1000research.144482.1)

Introduction

Pain is defined by the International Association for the Study of Pain as an “unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Pain perception begins before birth.1

The most used type of anaesthesia for cesarean sections is spinal anaesthesia. This approach is the best choice when there are no contraindications.2 It eliminates dangers associated with general anaesthesia, including awareness of the mother, aspiration of stomach contents, respiratory issues in the newborn, and difficulties managing the airway.3,4 Hypotension is the most common side effect of spinal anaesthesia and is closely linked to morbidity and death in both the mother and the fetus. Numerous investigations have demonstrated that despite preserving a comparatively brief duration of anaesthesia and analgesia, lowering the intrathecal local anaesthetic dose can lessen the incidence of spinal-induced hypotension.4

Following surgery, pain is unavoidable. Most essential organ functions are disrupted, and stress is caused by postoperative discomfort. These systems include the body’s metabolic, respiratory, cardiovascular, gastrointestinal, urological, and neuroendocrine. In addition to the discomfort brought on by pain, individuals recovering after surgery frequently experience difficulties breathing normally, coughing productively, and moving around enough to take care of their daily requirements or participate in rehabilitation. Feelings of hopelessness, terror, anxiety, and sadness are frequently the outcome of this. One of the scarier parts of surgery, in the eyes of the patient, is the postoperative pain. Thus, one of the primary duties of anesthesiologists is to relieve pain.

Many benefits come with appropriate postoperative pain management, such as increased patient comfort, quicker mobilization, fewer heart and lung issues, a decreased risk of deep vein thrombosis, a decreased chance of developing neuropathic pain, and a decreased medical expense. Therefore, to achieve prolonged and efficient postoperative analgesia, anesthesiologists typically have a keen interest in extending the duration of local anaesthesia.5

Many adjuvants, including epinephrine, phenylephrine, clonidine, and opioids, are used to lengthen the duration of spinal anaesthesia to solve the issue of the limited duration of action of local anaesthetics.4 Nevertheless, these adjuvants are linked to undesirable side effects. Many forms of regional anaesthesia have been treated with dexamethasone1,6,7 and dexmedetomidine8–12 as adjuvants without raising the risk of neurological problems.

Dexmedetomidine interacts with a transmembrane G protein-binding receptor and is a highly selective α2-adrenoreceptor agonist. Based on the research, it can be combined with local anaesthetics in spinal anaesthesia to accelerate the onset of the block, decrease the intensity of postoperative pain, prolong the block’s duration, and reduce the need for analgesics following surgery. By promoting vasodilatation and suppressing central thermoregulation, it reduces the frequency of shivering.13

Dexamethasone has been used as an intravenous drug to lessen shivering because it alters the body’s inflammatory response and lowers the gradient between central and peripheral tissue temperatures. We reasoned that dexamethasone might be used as an intrathecal adjuvant to local anaesthetics to reduce the intensity of shivering since it has been safely injected into the cerebrospinal fluid and used as an adjuvant to enhance the efficiency of regional anaesthesia.14 A 2011 study conducted in Iran looked at the effects of using 15 mg (3cc) of 0.5% hyperbaric bupivacaine in combination with 8 mg of dexamethasone for spinal anaesthesia during orthopaedic surgery. According to their observations, the duration of analgesia rose from 202±43.67 minutes (Control Group) to 401±72.44 minutes (Intervention Group).

Bupivacaine is a solid local anesthetic with unique features that was first discovered in 1957. It is a member of the amide group of local anesthetics. Local anesthetics are used in spinal anesthesia, regional anesthesia, epidural anesthesia, and local infiltration. Because they increase the threshold for electrical stimulation, local anesthetics frequently stop nerve cells from generating an action potential. The way anesthesia develops depends on a number of factors, including the diameter, degree of myelination, and conduction velocity of nerve fibers.

One major worry in obstetrics is the discomfort associated with caesarean procedures. Several studies have shown how important it is to provide adequate analgesia before, during, and after surgery to assist in mobilization, encourage rehabilitation, and reduce hospital stays. Our primary goal in this study is to compare how long postoperative analgesia lasts using dexamethasone versus dexmedetomidine. Comparing intraoperative sedation, intraoperative shivering, and intraoperative hemodynamics between dexamethasone and dexmedetomidine is the secondary goal.

Aim

Comparing the duration of analgesia caused by adding dexmedetomidine and Dexamethasone to bupivacaine during SAB (sub arachnoid block) for expectant mothers planned for elective LSCS.

Objectives

1) Primary objective

  • 1. Comparison of duration of analgesia between dexmedetomidine and Dexamethasone when added to bupivacaine.

2) Secondary objectives

  • 1. Comparing the effect of Dexamethasone and dexmedetomidine on intraoperative haemodynamics.

  • 2. Comparison of perioperative shivering and effect on sedating the patient.

Methods

After receiving approval from the Datta Meghe Institute of Education & Research,Sawangi(M), Wardha, DMIMS Institutional Ethical Committee and screening Committee, the study would be carried out in the Department of Anaesthesiology, J.N.M.C. Before the procedure, written and informed consent will be taken. A departmental steering committee will monitor the study’s progress until completion.

Study design

Two arm parallel interventional trial

Research design: Comparative Prospective

Study area: Department of Anaesthesiology J.N.M.C. & A.V.B.R.H.

Study period: 2 year

Study population: Patients undergoing elective caesarean section

Allocation of patient: Computer-generated randomization.

Inclusion criteria

  • 1. Age between 20 to 40 years

  • 2. Pregnant ladies who have scheduled c-sections

  • 3. Pregnant for more than 37 weeks

  • 4. Body mass index 20 to 29.9 kg/meter square

  • 5. Intact amniotic membrane

  • 6. No history of bleeding tendency

  • 7. Only caesarean sections as prior uterus surgeries

  • 8. Living fetus

  • 9. ASA class I and II

  • 10. Patients giving informed consent

Exclusion criteria

  • 1. Absence of legitimate, written, informed permission

  • 2. Those who have experienced bleeding disorders

  • 3. III and IV ASA

  • 4. Localized a block site infection

  • 5. Patient using anticoagulants at this time

  • 6. Patients with a history of musculoskeletal and neurological disorders

  • 7. Failed spinal

Sampling size

Fifty volunteers who match all inclusion criteria will take part in the trial.

Participants in the study will be divided into two groups at random (Table 1):

Table 1. Comparison between group A (Bupivacaine and dexmedetomidine) and group B (Bupivacaine and dexamethasone).

GroupDrug givenTotal volume
AIntrathecally injected dose of 10 mg of bupivacaine and 10 mcg of dexmedetomidine.2.1 ml
BIntrathecally injected doses of 8 mg dexamethasone and 10 mg bupivacaine.2 + 2 = 4 ml

Group A: Patients will receive intrathecally 10 mg of bupivacaine and 10 mcg of dexmedetomidine.

Group B: Patients will receive intrathecally injected doses of 8 mg dexamethasone and 10 mg bupivacaine.

Justification of sample size

The calculation of sample size is based on:

N=2α+2B2δ12+δ22/kΔ2

2α-It is the level of significance at 5% I.e 95% confidence interval = 1.96

2β-The power of test = 80% = 0.84

δ1-SD of timeto reach peak sensory level in group A = 0.32

δ2-SD of time to reach peak sensory level in group B = 0.32

Δ-Difference between two means = 6.93-6.5 = 0.43

Κ-1

N=1.96+0.8420.612+0.322/10.432=20.11

N = 25 patients needed in each group

Study reference: Mohamed Abdul Mohasen, Abdul Naiem Ismael et al.

Preoperative assessment

  • 1. All patients will have a pre-anesthesia examination the day before the procedure.

  • 2. A general examination, thorough evaluation, blood tests, and lab work will be recommended, along with basic patient information such as demographics, the history of the illness, and any present signs.

  • 3. The patients will be told of the study’s purpose, advantages, and disadvantages.

  • 4. Each patient participating in the study will provide written informed consent.

  • 5. They must abstain from food and drink for at least eight hours before the surgery.

  • 6. Participants in the study will be randomly divided into two groups.

Patients in Group A (n=25) will receive intrathecally ten10 mcg of dexmedetomidine and 10 mg of bupivacaine.

Patients in group B (n=25) will get intrathecally injected doses of 8 mg dexamethasone and 10 mg bupivacaine.

Intraoperative assessment

  • 1. Intraoperative attachments include an E.C.G, pressure monitor, and SpO2 probe.

  • 2. An IV line will be set up using an 18g IV cannula, and fluids(10- to 15 ml/kg) of Ringer lactate will be administered.

  • 3. Baseline measurements: The electrocardiogram from Lead II will be continuously displayed, and the patient’s blood pressure, heart rate, and SpO2 will also be recorded.

  • 4. Each patient will receive a prescription for premedication. Ondansetron 75–100 mcg/kg should be intravenously administered 10 minutes before the anaesthesia procedure.

  • 5. A 23/25 gauge Quinke’s needle will administer a subarachnoid block to the midline L3-4/L4-5 intervertebral space while maintaining the patient in a sitting or left lateral position. Then, the spinal needle’s introducer is grasped and carefully inserted through it until there is no longer any resistance, dural tissue is detected, and free flow of CSF is observed.

  • 6. Group A patients receive 2.1 ml of total drug volume, which consists of hyperbaric bupivacaine (2 ml) and dexmedetomidine(0.1 ml/10 mcgs) as an adjuvant.

  • 7. Patients in Group B get hyperbaric bupivacaine (2 ml) and Dexamethasone (2 ml/8 mg) administered sequentially in two different syringes for a total volume of 2 + 2 ml = 4 ml. After SAB (subarachnoid block), patients are immediately positioned to supine. First, Dexamethasone will be administered, followed by bupivacaine.

The following values will be noted.

  • 1. H.R., SBP, DBP, and SpO2 shall be recorded:

    • - Baseline/before (drug administration)

    • - 0, 3, 5, 10, 15 and 30 min following administration of the drug.

  • 2. Duration of analgesia will be measured with the help of VAS (visual analogue scale). It will be measured till the first rescue analgesia. In rescue analgesia first line will be iv paracetamol.

  • 3. Sedation grade using modified Richmond agitation sedation score

  • 4. Grade of shivering using Crossley and Mahajan grading of intraoperative shivering

  • 5. Negative outcomes, if any.

Statistical analysis plan

Analysis

Results over the outcome variables will be tabulated & described using descriptive statistics; data over the outcome variables will be tested for normal distribution for the mean and standard deviation (SD) median statistics will positioned for finding skewed distributions and interquartile range (IQR). Frequency and percentages for binary and categorical variables will be tabulated for descriptive statistics. R-software free version will be used for all statistical analysis. The inferential statistics will be analysed as per the description given below

Primary variable

Inferential statistics will be used for comparing the two groups for measurement score resulted for their mean change in primary variable (modified Richmond agitation sedation score, Crossley and Mahajan grading of intraoperative shivering, visual analogue scale) between baseline and end.

Outcome variables will be tested for intra difference in measurement at pre & post visits using paired t-test for finding the significance in mean. While for inter group difference unpaired t-test for comparison of two group.

For non-normal distribution Mathematical algorithms will be used for conversion of the data to normal distribution. If Data over primary variable still follows the non normal distribution then we will use alternate non parametric test Mann-Whitney and Wilcoxon test.

Categorial data will be evaluated using chi square analysis using for finding association at 5% level of significance with P-value ≤ 0.05.

Effect size over mean change difference on primary variable will be measured with corresponding 95% confidence interval (CI) & will be presented for finding the significance at 5% level.

Dissemination

We predict that Group B will have more prolonged and lasting analgesia than Group A during our investigation.

Study status

Continuous information collection going on.

Discussion

As it provides adequate anaesthesia and pain relaxation while eliminating general anaesthesia complications, spinal anaesthesia is a well-established technique used in caesarean sections. In order to produce prolonged and efficient postoperative analgesia, anesthesiologists usually worry about extending the duration of local anaesthetics.12 Numerous authors have employed Dexmedetomidine and Dexamethasone as adjuvants to local anaesthetics and have shown notable outcomes.

Dexmedetomidine, a targeted alpha-adrenoreceptor agonist, can prolong analgesia and anaesthesia in peripheral and neuraxial anaesthesia.11,13–17 Additionally, there is no relation with respiratory depression.18 In a preclinical study or clinical practice, there was no proof that intrathecal dexmedetomidine caused neurological deficits.19

Dexamethasone inhibits nociceptive C-fibre neuronal discharges, which gives it anti-inflammatory and analgesic effects. When taken intrathecally, Dexamethasone may impact the synthesis of intraspinal prostaglandins. It is still unclear exactly how analgesic activity works.19 The effects of intrathecal Dexamethasone have been encouraging. Few investigations have shown that Dexamethasone administered intrathecally prolongs the time the sensory block lasts and enhances postoperative analgesia without noticeable side effects.1,19–26

According to a study by Mohamed Abdul Mohsen Abdul Naiem Ismaiel et al., bupivacaine can be safely supplemented with Dexamethasone and dexmedetomidine. Dexamethasone prolongs the duration of postoperative analgesia, while during and following surgery, dexmedetomidine is more efficient at sedating the patient. However, according to research by Baher Said Abdelhady et al., higher analgesia and motor inhibition were observed in the dexmedetomidine category than in the dexamethasone category. In an elective caesarean operation, the average length of analgesia increased considerably with bupivacaine when Dexamethasone was added, according to a study by Muhammad Aatir Fayyaz et al. According to a study by Mahamoud Ali Ahmed El-Shourbagy et al., adding Dexamethasone to bupivacaine increases postoperative analgesia. According to a study by Ravi Gurbani, dexmedetomidine as an adjuvant extends the time that the block and postoperative analgesia last compared to Dexamethasone with little to no effect in upper limb surgery.

Ethical considerations

The JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI Research Project has received approval from the institutional ethics committee. The citation is D.M.I.M.S. (DU)/IEC/2022/96.

Data availability

No data are associated with this article.

Acknowledgements

The author would like to thank the Department of Anaesthesia, J.N.M.C., A.V.B.R.H., Sawangi, Wardha, India staff for their assistance.

References

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  • 7.  Marhofer P, Columb M, Hopkins PM: Perineural dexamethasone: the dilemma of systematic reviews and meta-analyses. Br. J. Anaesth. 2018; 120(2): 201–203. PubMed Abstract | Publisher Full Text
  • 8.  Yanshuai M, Shuang Q: Effects of dexmedetomidine in reducing postcesarean adverse reactions. Exp. Ther. Med. 2017; 14(3): 2036–2039.
  • 9.  Wu HH, Wang HT, Jin JJ, et al.: Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014; 9: e93114. PubMed Abstract | Publisher Full Text | Free Full Text
  • 10.  Safari F, Aminnejad R, Mohajerani SA, et al.: Intrathecal Dexmedetomidine and Fentanyl as Adjuvant to Bupivacaine on Duration of Spinal Block in Addicted Patients. Anesth. Pain Med. 2016; 6(1): e26714. PubMed Abstract | Publisher Full Text
  • 11.  Paramasivan A, Lopez-Olivo MA, Foong TW, et al.: Intrathecal dexmedetomidine and postoperative pain: A systematic review and meta-analysis of randomized controlled trials. Eur. J. Pain. 2020; 24(7): 1215–1227. PubMed Abstract | Publisher Full Text
  • 12.  Krishna TM, Panda N, Batra Y, et al.: Combination of low doses of intrathecal ketamine and midazolam with bupivacaine improves postoperative analgesia in orthopedic surgery. Eur. J. Anaesthesiol. 2008; 25(4): 299–306. PubMed Abstract | Publisher Full Text
  • 13.  Xia F, Chang X, Zhang Y, et al.: The effect of intrathecal dexmedetomidine on the dose requirement of hyperbaric bupivacaine in spinal anesthesia for caesarean section: a prospective, double-blinded, randomized study. BMC Anesthesiol. 2018; 18(1): 74. PubMed Abstract | Publisher Full Text | Free Full Text
  • 14.  Yanshuai M, Shuang Q: Effects of dexmedetomidine in reducing postcesarean adverse reactions. Exp. Ther. Med. 2017; 14(3): 2036–2039.
  • 15.  Wu HH, Wang HT, Jin JJ, et al.: Does dexmedetomidine as a neuraxial adjuvant facilitate better anesthesia and analgesia? A systematic review and meta-analysis. PLoS One. 2014; 9: e93114. PubMed Abstract | Publisher Full Text | Free Full Text
  • 16.  Safari F, Aminnejad R, Mohajerani SA, et al.: Intrathecal Dexmedetomidine and Fentanyl as Adjuvant to Bupivacaine on Duration of Spinal Block in Addicted Patients. Anesth. Pain Med. 2016; 6(1): e26714. PubMed Abstract | Publisher Full Text
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Patel S, Chandak A and Wanjari D. A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS [version 1; peer review: 1 approved, 1 not approved]. F1000Research 2024, 13:300 (https://doi.org/10.12688/f1000research.144482.1)
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Reviewer Report 03 Sep 2024
Michael Hofkamp, Baylor Scott and White Medical Center, Temple, Texas, USA 
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https://doi.org/10.5256/f1000research.158286.r316139
This is a prospective randomized controlled trial to compare postoperative pain control following spinal anesthesia for cesarean delivery between patients who received bupivacaine and dexamethasone and patients who received bupivacaine and dexmedetomidine.

The primary aim of the ... Continue reading
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Hofkamp M. Reviewer Report For: A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS [version 1; peer review: 1 approved, 1 not approved]. F1000Research 2024, 13:300 (https://doi.org/10.5256/f1000research.158286.r316139)
The direct URL for this report is:
https://f1000research.com/articles/13-300/v1#referee-response-316139
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 16 Aug 2024
Israel Kolawole, University of Ilorin, Ilorin, Nigeria 
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https://doi.org/10.5256/f1000research.158286.r306865
This is a good study with practical relevance to the practice of anaesthesia. The manuscript is well written with good grammatical style. The IASP definition of pain provided is outdated. It should be updated to the 2021 definition. The results ... Continue reading
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Kolawole I. Reviewer Report For: A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS [version 1; peer review: 1 approved, 1 not approved]. F1000Research 2024, 13:300 (https://doi.org/10.5256/f1000research.158286.r306865)
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  1. Israel Kolawole, University of Ilorin, Ilorin, Nigeria
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