Ketamine Versus Neostigmine in Ultrasound-Guided Transversus Abdominis Plane Block in Caesarean Section

NCT06871033 | Completed Phase 3 DMC

• 1 other identifier: 0201931
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The current study investigates the efficacy and safety of ketamine and neostigmine as adjuvants in transversus abdominis plane blocks for Cesarean sections. The study participants arerandomized into two groups, each receiving either ketamine or neostigmine alongside plain bupivacaine. Various parameters, including pain intensity, intraoperative and postoperative hemodynamics, rescue analgesia requirements, patient satisfaction, and postoperative complications, are evaluated and compared between the two groups.

Conditions

Caesarian Section; Postoperative Pain

Keywords

Ketamine; Neostigmine; TAP block; Caesarian section; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Post operative pain score

  Change From Baseline in Pain Scores on the Visual Analog Scale

  Intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively

Secondary Outcomes (1)

• Patient satisfaction

  24 hours postoperative

Study Arms (2)

TAP block with Ketamine

ACTIVE COMPARATOR

40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side

Drug: TAP block with Ketamine

TAP block with Neostigmine

EXPERIMENTAL

40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side.

Drug: TAP block with neostigmine

Interventions

TAP block with neostigmine DRUG

40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side.

TAP block with Neostigmine

TAP block with Ketamine DRUG

40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side.

TAP block with Ketamine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II patients.

You may not qualify if:

• Patients undergoing emergent CS.
• Patient refusal.
• Allergy to local anaesthesia or any additive drug.
• Coagulopathy.
• Body mass index \> 35.
• Peripheral neuropathy or chronic pain syndrome.
• Localized infection.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine Alexandria University

Alexandria, Alexandria Governorate, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Neostigmine; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2023-12

Locations

EG (1)