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

Mansoura University

Status: Not yet enrolling

Conditions: Analgesia

Treatments: Drug: Bupivacaine; Drug: Bupivacaine-Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT05785377

TAP-neostigmine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Bupivacaine group (Group-B)

Placebo Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Bupivacaine-Neostigmine group (Group-BN)

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine-Neostigmine