Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia (TAB)

Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.

Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.

Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) 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 Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Drug: Bupivacaine; Drug: Bupivacaine-Neostigmine

Detailed Description

This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of neostigmine as an adjuvant to isobaric bupivacaine inTranversus abdominis plane (TAPB) for postoperative analgesia in cesarean section under spinal anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha AboZeid, MD; Phone Number: 02-01019216192; Email: mahazed@mans.edu.eg

Study Locations

• Egypt
  • Mansoura
    • El Mansoura, Mansoura, Egypt, 35511
      • Mansoura University-Emergency hospital-ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 19 to 40 years old
• American Society of Anesthesiologists (ASA) physical status II patients
• Singleton pregnancies with a gestational age of at least 37 weeks.
• Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.

Exclusion Criteria:

• Age < 19 or > 40 years.
• Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
• Inability to comprehend or participate in the pain scoring system.
• Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
• Hypersensitivity to any drug used in the study.
• Any hypertensive disorders of pregnancy.
• Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
• Significant cardiovascular, renal or hepatic abnormalities.
• Patients with history of opioid intake, drug abusers or psychiatric patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Bupivacaine group (Group-B); After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of normal saline (Total volume of 21mL in each side	Drug: Bupivacaine; 20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%
Active Comparator: Bupivacaine-Neostigmine group (Group-BN); After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of 500 mcg neostigmine (Total volume of 21mL in each side	Drug: Bupivacaine-Neostigmine; 20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of the first postoperative analgesic requirement	during the first 24 postoperative hours	during the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the	mg	during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest	11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively	during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement	11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively	during the first 24 postoperative hours
Mean arterial blood pressure (MBP)	mmHg	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)	beat per minute	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Patient satisfaction about the quality of postoperative analgesia	poor = 1, fair = 2, good = 3, excellent = 4	during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)	incidence	during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome		during the first 24 postoperative hours

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: TAP-neostigmine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No