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NCT Number: NCT05785377

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

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.

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Key information

Conditions

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

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University-Emergency hospital-ICU

El Mansoura, Mansoura, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-Neostigmine

Drug

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

Bupivacaine

Drug

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

Primary outcomes

  1. The time of the first postoperative analgesic requirement

    Time frame: during the first 24 postoperative hours

    during the first 24 postoperative hours

Secondary outcomes

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

    Time frame: during the first 24 postoperative hours

    mg

  2. The visual analog scale (VAS) scores during rest

    Time frame: during the first 24 postoperative hours

    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

  3. The visual analog scale (VAS) scores during movement

    Time frame: during the first 24 postoperative hours

    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

  4. Mean arterial blood pressure (MBP)

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

    mmHg

  5. heart rate (HR)

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

    beat per minute

  6. Patient satisfaction about the quality of postoperative analgesia

    Time frame: during the first 24 postoperative hours

    poor = 1, fair = 2, good = 3, excellent = 4

  7. The side effects (nausea, vomiting, abdominal colic and lower limb weakness)

    Time frame: during the first 24 postoperative hours

    incidence

  8. the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome

    Time frame: during the first 24 postoperative hours

Study contacts

Contact information is provided by the study sponsor or research team.

Maha AboZeid, MD

CONTACT

[email protected]

02-01019216192

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: TAB

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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