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

NCT05785377 | Not Yet Recruiting

• 1 other identifier: TAP-neostigmine
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The time of the first postoperative analgesic requirement

  during the first 24 postoperative hours

  during the first 24 postoperative hours

Secondary Outcomes (8)

• Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the

  during the first 24 postoperative hours

• The visual analog scale (VAS) scores during rest

  during the first 24 postoperative hours

• The visual analog scale (VAS) scores during movement

  during the first 24 postoperative hours

• Mean arterial blood pressure (MBP)

  basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

• heart rate (HR)

  basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

Study Arms (2)

Bupivacaine group (Group-B)

PLACEBO COMPARATOR

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

Bupivacaine-Neostigmine group (Group-BN)

ACTIVE COMPARATOR

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

Interventions

Bupivacaine-Neostigmine DRUG

20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg)

Bupivacaine-Neostigmine group (Group-BN)

Bupivacaine DRUG

20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%

Bupivacaine group (Group-B)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: singleton pregnant women with a gestational age of at least 37 weeks
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

El Mansoura, Mansoura, 35511, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Maha AboZeid, MD

CONTACT

02-01019216192; mahazed@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into two groups; Group-B and Group-BN according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: March 27, 2023
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)