MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section

Summary

The aim of this study is to compare the duration of analgesia obtained by addition of Neostigmine versus MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Cesarean Section and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.

Conditions

• Cesarean Section

Interventions

PROCEDURE

transversus abdominis plane (TAP) block in cesarean section

.an intravenous (IV) access will be secured . Standard ASA monitoring will be instituted which include(SpO2), ECG and (NIBP) . At the end of surgery , a bilateral USG-guided TAP block will be carried out under strict aseptic precautions, and 20 mL of study solution was injected into each side. After draping the abdominal region between the 12th rib and anterior superior iliac crest with the umbilicus in the center, the external oblique muscle, internal oblique muscle, transversus abdominis muscle , and their fascia will be located beneath the skin and subcutaneous tissue using a linear high-frequency probe 6-13 Megahertz of the SonoSite Micromax machine. A 22-gauge spinal needle will be advanced using the in-plane technique at the anterior axillary line, and the precise position of the needle tip between the internal oblique and transverse abdominis muscle will be visualized. To expand the plane, 2 mL of normal saline will be administered.

DRUG

Magnesium sulfate

25ml volume on each side (20ml of 0.25% bupivacaine plus 5ml of normal saline containing 250 mg of MgSO4) to keep the total volume the same in both group

DRUG

Neostigmine

25ml volume on each side (20ml of 0.25% bupivacaine plus 5ml of normal saline containing 500 mcg neostigmine. A 22-gauge spinal needle will be advanced using the in-plane technique at the anterior axillary line, and the precise position of the needle tip between the internal oblique and transverse abdominis muscle will be visualized. To expand the plane, 2 mL of normal saline will be administered. Following the affirmation of a hypoechoic region on the USG image, the study solutions will be injected as per group allocation. Postoperatively,both groups of patients received an injection of paracetamol 1gm intravenously every 8th hourly as a part of multimodal analgesia and the patients will be evaluated for pain, nausea or vomiting in the post anaesthesia care unit at time 0 (time of completion of TAP block), 2, 4, 6,12 and 24 h by an investigator blinded to the group assignment. Whenever the NRS \>4, Nalbuphine 0.1 mg/kg IV will be administered as a rescue analgesic.

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Zain Alabdin Zaree Hassan · Assiut University

• Nashwa Farouk Abdel Hafez · Assiut University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-20

Primary Completion

2026-01-18

Completion

2026-01-18

Countries

• Egypt

Study Locations