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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TAP Block
• Intervention / Treatment: Drug: transversus abdominis plane (TAP) block in Abdominal hysterectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ahmed Hamdy Mohamed Saleh, Resident; Phone Number: +201010958730; Email: abohamdy753@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M "bupivacaine +normal saline +MgSO4"; 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; 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.
Active Comparator: Group D "bupivacaine +normal saline +dexamethasone"; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Zain Alabdin Zaree Hassan, Professor, Assiut University; Study Director: Ahmed Talaat Ahmed, Lecture, Assiut University

Publications and helpful links

General Publications

• Balakrishna KP, Kagalkar ND, Suntan A. Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Abdominal Hysterectomy Surgeries. Cureus. 2023 Apr 5;15(4):e37156. doi: 10.7759/cureus.37156. eCollection 2023 Apr.
• Shambhavi T, Das S, Senapati LK, Padhi PP. Comparative evaluation of bupivacaine with magnesium sulphate and dexamethasone as adjuvants in ultrasound-guided transversus abdominis plane block for open unilateral inguinal hernia surgeries: A randomised controlled trial. Indian J Anaesth. 2023 Apr;67(4):370-375. doi: 10.4103/ija.ija_1091_21. Epub 2023 Apr 10.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TAP block in Hysterectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No