Magnesium Sulphate Versus Dexamethasone as an Adjuvant to Bupivacaine in TAP Block for Abdominal Hysterectomy

Study Overview
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Brief Summary
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The aim of this study is to compare the duration of analgesia obtained by addition of dexamethasone and MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Total Abdominal Hysterectomy and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.

Detailed Description
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Total abdominal hysterectomy (TAH) is accompanied by an extensive inflammatory response resulting in postoperative discomfort and misery. Such patients require appropriate analgesic treatment to reduce morbidity and complications by blunting autonomic, somatic, and endocrine reflexes. As a result, postoperative analgesia following TAH calls for a multimodal approach. One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia. This block implies administering local anesthetic between the internal oblique muscle and transversus abdominis muscle, which is marked by the lumbar Petit triangle. The primary drawback of single-shot regional blocks is their short duration of action when administered with local anesthetic alone. Several adjuvants, including opioids, alpha 2 agonists, N-methylD-aspartate (NMDA) receptor antagonists, and other drugs, have been utilized to extend the duration of blocks. Opioids are by far the most often used adjuvants, but they accompany a host of unpleasant side effects, such as respiratory depression, drowsiness, nausea, and vomiting. In some studies, using alpha 2 agonists such as Dexmedetomidine and Clonidine has been related to drowsiness and bradycardia. MgSO4 is an N-methyl-D-aspartate (NMDA) receptor antagonist. It acts by non-competitive antagonism blocking the voltage-dependent ion channels. Dexamethasone is a highly potent, long-acting glucocorticoid. It inhibits potassium conductance by binding to glucocorticoid receptors which decrease the activity of nociceptive C-fibres and may also prolong the analgesia duration through systemic anti'-inflammatory effects and local vasoconstrictive action.

Official Title
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Comparative Evaluation of Magnesium Sulphate Versus Dexamethasone as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block for Abdominal Hysterectomy as Postoperative Analgesia

Conditions
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TAP Block

Intervention / Treatment
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* Drug: transversus abdominis plane (TAP) block in Abdominal hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 35-70 years Female patients American society of anesthesiologists (ASA) physical state I-II Undergoing Total Abdominal Hysterectomy Exclusion Criteria: Patient's refusal Cardio-respiratory conditions Convulsions Local infection at the block's site Bleeding diathesis Known allergy to any drugs used in this study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M bupivacaine +normal saline +MgSO4<br>will receive 25 ml volume on each side (20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 250 mg of MgSO4) | Drug: transversus abdominis plane (TAP) block in Abdominal hysterectomy<br>* Comparative evaluation of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound guided transversus abdominis plane block for Abdominal hysterectomy as postoperative analgesia.<br>|
| Active Comparator: Group D bupivacaine +normal saline +dexamethasone<br>will receive 25ml volume on each side (20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 8 mg of dexamethasone) | Drug: transversus abdominis plane (TAP) block in Abdominal hysterectomy<br>* Comparative evaluation of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound guided transversus abdominis plane block for Abdominal hysterectomy as postoperative analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparasion of postoperative NRS score for 24 hours between the two groups | NRS Score: used to assess pain intensity. It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analogue scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hemodynamic parameters | Hemodynamic parameters including HR(beat/min), MAP(mmHg), and SpO2(%) | 24 hours postoperative | 
| Time required for the first rescue analgesia | the time at which the patient demand analgesia will be recorded for each patient | 24 hours postoperative | 
| Total amount of rescue analgesic consumption during the first 24 hours postoperatively |  | 24 hours postoperative | 
| Patient satisfaction score | Five-points Likert scale: to evaluate the patients' satisfaction regarding the whole procedure at the end of the postoperative 24 hours. It ranged from (1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied) | 24 hours postoperative | 
| PONV intensity by postoperatively | The number of attacks of nausea for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h and will be recorded as yes/no. •The number of attacks of vomiting for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h postoperatively and will be recorded as yes/no. | 24 hours postoperative |