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

Phase 2

Not yet recruiting

• Conditions: Cesarean Section
• Interventions: Procedure: transversus abdominis plane (TAP) block in cesarean section; Drug: Magnesium sulfate; Drug: Neostigmine

• Registration Number: NCT06513013
• Lead Sponsor: Assiut University

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.

Detailed Description

Caesarean section (CS) is one of the most operations in the world. Effective postoperative analgesia after it is very important because it encourages breast feeding and facilitates early ambulation and recovery. Postoperative analgesia is too important to prevent unwanted side effects such as venous thromboembolism, respiratory complications and increased hospital stay.Post Caesarean discomfort and pain is expected; so, the analgesic regimen should assure safe and efficient sedation. Commonly, opioids and NSAIDs are used for post caesarean pain relief. While dose dependent respiratory depression is the most discomforting side effect, other insignificant side effects such as gastrointestinal upset, pruritus and urinary retention can be annoying during the first hours of puerperium. The transversus abdominus plane (TAP) block has been used for postoperative pain relief in different abdominal surgeries as part of the multimodal anesthetic approach.It creates satisfactory somatic anesthesia with no visceral blockade. 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,Neostigmine, 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.

The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves. 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study Start: 2024-07-20
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M "bupivacaine + normal saline + MgSO4"	transversus abdominis plane (TAP) block in cesarean section	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 )
Group M "bupivacaine + normal saline + MgSO4"	Magnesium sulfate	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 )
Group D "bupivacaine + normal saline + Neostigmine"	transversus abdominis plane (TAP) block in cesarean section	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
Group D "bupivacaine + normal saline + Neostigmine"	Neostigmine	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

Primary Outcome Measures

Name	Time	Method
comparasion of Postoperative NRS score for 24 hours between the two groups	24 hours postoperative	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.

Secondary Outcome Measures

Name	Time	Method
postoperative hemodynamic parameters	24 hours postoperative	Hemodynamic parameters including HR
time required for the first rescue analgesia	24 hours postoperative	the time at wich the patient demand analgesia will be record for each patient
total amount of rescue analgesic consumption duringfirst 24 hours postoperatively	24 hours postoperative	total amount of rescue analgesic consumption duringfirst 24 hours postoperatively
patient satisfacation score	24 hours postoperative	five-point likert scale: to evaluate the patient satisfacation regarding the; 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)
PONV intensity by postoperatively:	24 hours postoperative	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.