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

NCT06513013 | Completed Phase 2

• 1 other identifier: TAP in cs using us
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TAP; mg sulphate

Outcome Measures

Primary Outcomes (1)

• comparasion of Postoperative NRS score for 24 hours between the two groups

  NRS Score: used to assess pain intensity (13). It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog 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 (Figure 2). This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.

  24 hours postoperative

Secondary Outcomes (5)

• postoperative hemodynamic parameters

  24 hours postoperative

• time required for the first rescue analgesia

  24 hours postoperative

• total amount of rescue analgesic consumption duringfirst 24 hours postoperatively

  24 hours postoperative

• patient satisfacation score

  24 hours postoperative

• PONV intensity by postoperatively:

  24 hours postoperative

Study Arms (2)

Group M "bupivacaine + normal saline + MgSO4"

ACTIVE COMPARATOR

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 )

Procedure: transversus abdominis plane (TAP) block in cesarean section; Drug: Magnesium sulfate

Group D "bupivacaine + normal saline + Neostigmine"

ACTIVE COMPARATOR

will receive 25 ml volume on each side ( 20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 500 mcg of Neostigmine

Procedure: transversus abdominis plane (TAP) block in cesarean section; Drug: Neostigmine

Interventions

transversus abdominis plane (TAP) block in cesarean section PROCEDURE

.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.

Group D "bupivacaine + normal saline + Neostigmine"; Group M "bupivacaine + normal saline + MgSO4"

Magnesium sulfate DRUG

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

Group M "bupivacaine + normal saline + MgSO4"

Neostigmine DRUG

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.

Group D "bupivacaine + normal saline + Neostigmine"

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 19 to 40 years old
• Singleton pregnencies with a gestational age of at least 37 weeks
• American society of anesthesiologists (ASA) physical state I , II
• patients undergoing spinal anesthesia for cesarean delivery via Pfannenstiel incision with exteriorization of the uterus.

You may not qualify if:

• Patient's refusal
• Age \< 19 or \> 40 years
• Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
• Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
• Cardio-respiratory conditions
• Convulsions
• Inability to comprehend or participate in the pain scoring system.
• Bleeding diathesis
• Known allergy to any drugs used in this study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women's Health Hospital, Assiut University

Asyut, Egypt

Location

Related Publications (3)

• Kapral S, Gollmann G, Waltl B, Likar R, Sladen RN, Weinstabl C, Lehofer F. Tramadol added to mepivacaine prolongs the duration of an axillary brachial plexus blockade. Anesth Analg. 1999 Apr;88(4):853-6. doi: 10.1097/00000539-199904000-00032.

  PMID: 10195537 BACKGROUND

• Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.

  PMID: 31649394 BACKGROUND

• Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.

  PMID: 20216023 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion; Cesarean Section; Magnesium Sulfate; Neostigmine

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Zain Alabdin Zaree Hassan

  Assiut University

  STUDY CHAIR

• Nashwa Farouk Abdel Hafez

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 22, 2024
• Study Start: December 20, 2023
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

EG (1)