Keywords
Ropivacaine, magnesium sulphate, peripheral nerve stimulator, supraclavicular plexus block, postoperative analgesia, upper limb surgeries.
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Postoperative pain management is a crucial part of patient care for surgeries involving the upper limbs. A popular technique for providing both postoperative analgesia and regional anaesthesia is a supraclavicular plexus block guided by a peripheral nerve stimulator. Recent research has demonstrated that the analgesic effect of ropivacaine, a common local anaesthetic, can be enhanced by the addition of magnesium sulphate.
The study aims to assess the safety and effectiveness of utilising magnesium sulphate in addition to ropivacaine alone for postoperative analgesia in patients having upper limb surgeries under peripheral nerve stimulator-guided supraclavicular plexus block.
This protocol outlines a prospective, double-blind, randomised, controlled trial that assesses the efficacy of ropivacaine versus ropivacaine plus magnesium sulphate for analgesia post surgery in patients undergoing upper limb surgeries under the guidance of a peripheral nerve stimulator (PNS). 50 Patients will be included in the study in total, and they will be split into two groups at random. PNS-guided supraclavicular plexus block with ropivacaine alone will be administered to one group, while ropivacaine combined with magnesium sulphate will be administered to the other. Regular monitoring will be done during the postoperative phase to determine pain levels, use of analgesics, motor and sensory blockade, and adverse events.
The study aims to determine if ropivacaine with magnesium sulphate postoperative analgesia is superior to ropivacaine alone in supraclavicular plexus blocks. The motor and sensory blockade duration, opioid use, and any negative results will be evaluated as secondary outcomes. Statistical analysis will be performed to determine the significance of the differences between the two groups.
This study protocol compares the effectiveness of ropivacaine alone against ropivacaine with magnesium sulphate in peripheral nerve stimulator-guided supraclavicular plexus block, with the goal of adding to the repository of information on postoperative analgesia in upper limb procedures. The study’s findings could be very helpful in enhancing pain management strategies and enhancing patient outcomes in this context.
Ropivacaine, magnesium sulphate, peripheral nerve stimulator, supraclavicular plexus block, postoperative analgesia, upper limb surgeries.
When opposed to general anaesthesia, regional anaesthesia is becoming a more popular option because it temporarily reduces pain and nerve transmission in particular body parts while maintaining awareness through the use of local anaesthetic medications.1 The brachial plexus block, a method that provides anaesthesia from the shoulder to the fingertips, is frequently used in upper limb procedures, which is where this tendency is most noticeable. The best method for blocking the brachial plexus will rely on a number of variables, such as the specific surgical indication, the patient’s attributes, anatomical variations, and medical concerns.2 The introduction of ultrasonography-guided techniques has greatly improved the accuracy and efficiency of these treatments. These developments have helped to increase success rates, enhance pharmacodynamics, and lessen systemic side effects, which has led to the acceptance of regional anaesthesia as a crucial part of contemporary surgical care.3
Important ramifications of managing postoperative pain include early mobilisation, reduced risk of deep vein thrombosis, cardiac and pulmonary problems, swift recovery, fewer healthcare costs, and higher patient satisfaction. Peripheral nerve blocks have therefore become an essential tool for achieving these goals as part of a more comprehensive multimodal analgesic approach.
When compared to other drugs such as bupivacaine, ropivacaine, a well-known aminoamide local anaesthetic, has gained favour due to its relative cardiac and neurologic safety profile. One benefit is that it produces a less severe motor block and takes less time, so patients can be mobilised and discharged sooner.4
Local anaesthetics by nature have a short half-life. Researchers have experimented with adding adjuvants to local anaesthetic solutions in order to produce denser blocks, accelerate onset, and prolong analgesia. By lowering the overall amount of local anaesthetic utilised and minimising systemic side effects, these adjuvants seek to improve analgesic effects.5 Magnesium sulphate is a naturally occurring intracellular cation that has gained interest among these adjuvants. It is essential for controlling nerve activity and may have effects akin to those of medications that limit calcium entry. Because of its capacity to control calcium influx into cells and inhibit N-methyl-D-aspartate receptors, magnesium is thought to have antinociceptive qualities. These effects lessen the need for anaesthesia and the amount of postoperative analgesics used.6 Numerous clinical investigations have documented the advantages of magnesium administration, including its use during general anaesthesia, which has resulted in a drop in the amount of opioids used and a reduction in the total dose needed for analgesia. Magnesium has shown the ability to improve analgesic characteristics when used as an adjuvant in perineural injection with local anaesthetic in the supraclavicular block.7
The main goal of the research is to make a contribution to the current discussion on the best ways to manage pain after upper limb procedures. Through a thorough investigation of the safety and effectiveness of ropivacaine in combination with magnesium sulphate, this study aims to offer important knowledge to medical practitioners, which will ultimately lead to better patient outcomes and increased delivery efficiency in this crucial clinical area.
To assess the safety and effectiveness of utilising magnesium sulphate in addition to ropivacaine alone for postoperative analgesia in patients having upper limb surgeries under peripheral nerve stimulator guided supraclavicular plexus block.
This research compares the effects of adding magnesium sulphate as an adjuvant to ropivacaine in patients undergoing upper limb operations with supraclavicular plexus block guided by a peripheral nerve stimulator. The analysis will be centred on the use of opioids and pain scores.
- To evaluate and compare the sensory and motor blockade onset and duration in the upper limb between both groups.
- To monitor and evaluate the patient’s hemodynamics during the surgery and in the postoperative period.
- To investigate the incidence of any side effects associated with the study drugs in both groups.
- Study design – This will be a prospective, randomised, double-blind, controlled trial to compare the safety and effectiveness of using magnesium sulphate as an adjuvant to ropivacaine in patients having upper limb surgeries with supraclavicular plexus block guided by a peripheral nerve stimulator.
- Study setting – The study will take place in the Anaesthesiology Department of Jawaharlal Nehru Medical College, Sawangi, Wardha.
- Study duration – Two years.
- Study population
○ Inclusion criteria
○ Exclusion criteria
▪ Patients having a known allergy to ropivacaine or magnesium sulphate,
▪ Patients with contraindications to supraclavicular plexus block, like, coagulopathies, infection at the site of infection, or sepsis,
▪ Patients having neurological disorders that potentially interfere with the assessment of motor or sensory blockage,
▪ Pregnant or lactating women, as there is insufficient evidence to support the safety of magnesium sulphate in this group,
▪ Patients suffering from severe cardiovascular, lung, or renal disorders, or other uncontrolled systemic diseases,
▪ Patients not willing to participate in the study.
The sample size was calculated in openepi.com using the duration of motor block in minutes as criteria from the study by Gupta et al.8 as seen in Figure 1. The study will be conducted on 50 patients with 25 patients in each group, to account for any possible dropouts.
Computer-generated random numbers will be used for randomization, and patients will be assigned in a 1:1 ratio to one of the two therapy groups. Neither the researchers nor the patients will know the randomization code. The trial will remain blinded throughout, and data collection will be done by an anaesthesiologist, not involved in the preparation of the study drugs.
Pre-operative assessment
Before the surgery, a thorough preoperative assessment will be conducted, a day prior to the scheduled surgery. During this assessment, patients’ details will be recorded, and routine laboratory investigations will be carried out. The patients will be briefed on the study protocol, the brachial plexus block procedure, and the use of the Visual Analog Scale (VAS) for pain assessment. Informed written consent will be obtained from each patient. Patients will be kept NPO for 6 hours before the procedure.
Intra-operative
On the day of the surgery, patients will be assessed in the preoperative room. They will be assigned between the two study groups using the computer-generated random numbers allocation method. The drug solution for each patient will be prepared by an independent anesthesiologist according to the assigned group. The two groups will be as follows.
Group R – Patients in this group will receive a solution of 24 mL of 0.5% ropivacaine with 6 ml of normal saline to make a total volume of 30 ml.
Group M – Patients in this group will receive a solution of 24 mL of 0.5% ropivacaine with 150mg of magnesium sulphate and 5.5 ml of normal saline to make a total volume of 30 ml.
An anesthesiologist who is not aware of the composition of the medication solution will perform the brachial plexus block technique. The group assignments and specific medications administered will remain hidden from both the patients and those in charge of documenting observations.
Upon arrival in the operating room, intravenous (IV) access will be established, and patients will receive a dose of 0.5-1 mg of midazolam IV for preoperative relaxation. Baseline measurements of heart rate (HR), mean arterial pressure (MAP), and oxygen saturation (SpO2) will be recorded. Subsequent measurements of these parameters will be taken at 15-minute intervals throughout the surgical procedure. A peripheral nerve stimulator will be used to perform the supraclavicular brachial plexus block, and the drug solution will be delivered in accordance with the research group.
For twenty minutes after the medication injection, the sensory blockade in the distribution of the ulnar, median, radial, and musculocutaneous nerves will be evaluated every two minutes on a 4-point scale. A sensory block that is ≥3 is regarded as appropriate for surgery; the time taken to reach this level will be noted as the beginning of the block. A score of 1 indicates complete sensation, 2 indicates faint sensation, 3 indicates light touch, and 4 indicates no sensation. A three-point grading system will be used to assess the motor blockade: Grade 0 will denote normal motor function, meaning the arm can be moved; Grade 1 will show decreased motor strength, meaning only the fingers can be moved; and Grade 2 will denote complete motor block, meaning the elbow, wrist, and fingers cannot be moved. The amount of time that passes between the drug injection and the development of a full motor block (Grade = 2) will be used to determine when the motor block starts. In instances in which the block is insufficient, endotracheal intubation and general anaesthesia will be used, and these patients will not be included in the statistical analysis. Using a VAS score, the effectiveness of postoperative analgesia will be assessed 2, 4, 6, 8, 12, and 24 hours after surgery. Patients will receive an intravenous injection of 75 mg of diclofenac as rescue analgesia if they seek further pain therapy. The time interval between the delivery of the block and the initial request for rescue analgesia will be used to determine the duration of analgesia. Pneumothorax, hematoma, postoperative paresthesias, excessive sedation, nausea, and vomiting are examples of procedure-related complications that will be noted and managed.
Data will be gathered by anesthesiologists using a standardised data collection form to ensure that there is uniformity in the collected data.
The statistical analysis will include a comparison of the results between the two treatment groups. Descriptive statistics such as means, standard deviations, and percentages will be used to summarise the data. To assess the significance of the group differences, inferential statistics such as regression analyses, chi-square tests, and t-tests will be employed.
The findings of the study will be sent to reputed medical journals, specializing in anesthesia for peer review and publication.
All participants will give their informed consent in accordance with the standards of medical ethics. Ethical approval has been received from the Institutional Ethical Committee (Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha. Ref. No. DMIMS (DU)/IEC/2022/95). Patient privacy and confidentiality shall be upheld.
Participants for both the ropivacaine and ropivacaine with magnesium sulphate groups have been successfully selected; the recruitment procedure was initiated earlier. Computer-generated randomization was used in the selection procedure to guarantee a methodical and objective assignment of patients to the appropriate groups. We have done 13 cases in the ropivacaine group and 12 cases in the ropivacaine with the magnesium sulphate group.
For upper limb procedures, the decision to use a peripheral nerve stimulator-guided supraclavicular plexus block is important because it may provide better pain management without having the systemic adverse effects that are frequently connected to general anaesthesia. Given the increasing amount of evidence bolstering the use of adjuvants to improve analgesia, the choice to look into the possibility of adding magnesium sulphate as an adjuvant to ropivacaine is followed in this study.9
Numerous clinical studies have shown that giving magnesium during general anaesthesia lowers the need for anaesthesia and the amount of analgesics used after surgery. Ropivacaine is less neurotoxic and cardiotoxic than other aminoamides, such as bupivacaine. Ropivacaine causes a shorter-lasting and less severe motor block than bupivacaine, allowing for speedier mobilisation and discharge.10 Mukherjee et al. found that although there was a slight delay in the onset time of sensory and motor blockade, adding 150 mg of magnesium sulphate to ropivacaine 0.50% in supraclavicular brachial plexus block resulted in a longer duration of sensory and motor blockade and a reduced need for rescue analgesics.11 Conversely, Shridevi et al. noticed positive results when magnesium sulphate was used as an adjuvant, showing both a quicker start and a longer duration of motor and sensory anaesthesia.12 Similarly, Kaur et al. discovered that postoperative analgesia was enhanced by adding 250 mg MgSO4 and 2 mg.kg−1 ketamine to 0.5% ropivacaine as opposed to ropivacaine alone. In the setting of supraclavicular brachial plexus block, MgSO4 demonstrated superiority in terms of block features and a lower frequency of adverse effects.13 In their comparison of dexmedetomidine and MgSO4 as adjuvants to ropivacaine, Shukla et al. found that while both were helpful, dexmedetomidine offered prolonged analgesia, an earlier onset of sensory and motor block, and a longer duration of block. The investigation also emphasised variations in adverse event patterns, wherein dexmedetomidine demonstrated a greater frequency of bradycardia, sedation, and hypotension.14 According to Chadha et al.’s study, the volume of 0.5% ropivacaine utilised in ultrasound-guided supraclavicular brachial plexus block decreased from 35 mL to 20 mL, which led to a 21% reduction in the length of analgesia. This highlights the significance of determining the lowest effective ropivacaine volume needed to achieve a full sensory and motor block with the least amount of IV analgesia needed.15 As adjuvants to ropivacaine, Kumari et al. examined dexmedetomidine and clonidine and discovered that dexmedetomidine produced a noticeably longer duration of postoperative analgesia and an earlier sensory block. The combination of ropivacaine and dexmedetomidine showed promise in this trial, especially for orthopaedic surgeries.16
The purpose of this study is to examine how well magnesium sulphate works with ropivacaine to prevent post-operative analgesia following upper limb procedures. A thorough research approach to address the critical problem of postoperative pain management in patients undergoing upper limb procedures is outlined in the study protocol that is being presented. Effective postoperative pain management is vital due to its significant influence on patient outcomes, recovery, and the healthcare system as a whole. Through a comparison of the two anaesthesia approaches’ efficacy and safety, this study protocol aims to give clinicians evidence-based counselling and shed light on the advantages of mixing magnesium sulphate with ropivacaine. By doing this, the study hopes to improve patient satisfaction, lower healthcare costs, accelerate recovery, and optimise patient outcomes. Although the study has great potential, there will likely be difficulties, such as finding patients, adhering to protocol, possible variation in surgical techniques, and ethical issues. Careful management of these obstacles is necessary to guarantee the validity and generalizability of the study.
To sum up, the study protocol offers a methodical and well-organized research strategy that tackles an important clinical concern in anesthesiology. This research has the potential to greatly improve postoperative pain management and, in turn, improve patient care in the setting of upper limb procedures by comparing the efficacy of various anaesthetic approaches. Attaining this goal will require meticulous protocol execution, ethical standards observance, and in-depth data analysis.
The scope of this study includes a detailed examination of the relative safety and efficacy of ropivacaine when combined with magnesium sulphate in supraclavicular brachial plexus block. The research aims to shed light on several brachial plexus block-related areas, with a particular emphasis on the degree of sensory and motor blockade, the analgesic’s duration, intensity, and onset.
The author would like to acknowledge the support from the staff of the Department of Anaesthesia, JNMC, AVBRH, Sawangi, Wardha, India.
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Is the rationale for, and objectives of, the study clearly described?
Partly
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Regional anesthesia, paediatric anesthesia.
Alongside their report, reviewers assign a status to the article:
Invited Reviewers | |
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Version 1 07 May 24 |
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