Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block

NCT06935669 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: FMASU MD36/2025
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the efficacy of transversalis fascia plane block using bupivacaine and ketamine versus bupivacaine alone for pain management after cesarean section under spinal anaesthesia.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The mean VAS pain on movement will be recorded as the primary outcome of the study

  Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain. Patients will report their pain levels at rest and during movement at 24 hours after the transversalis fascia plane block. The mean VAS score will be compared between the ketamine + bupivacaine group and the bupivacaine-only group.

  day 1

Secondary Outcomes (2)

• Time to first rescue analgesia will be recorded

  Day 1

• total requirements of rescue analgesia Nalbuphine over the first 24 hours postoperative will be recorded

  Day 1

Study Arms (2)

Ketamine and bupivacaine

EXPERIMENTAL

Transversalis fascia plane block

Drug: Ketamine; Drug: Bupivacain

Bupivacaine alone

ACTIVE COMPARATOR

Transversalis fascia plane block

Drug: Bupivacaine

Interventions

Ketamine DRUG

Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.

Also known as: Ketalar

Ketamine and bupivacaine

Bupivacaine DRUG

Control group to evaluate the additional effect of ketamine in the experimental arm.

Also known as: Marcaine

Bupivacaine alone

Bupivacain DRUG

Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.

Also known as: Marcaine

Ketamine and bupivacaine

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aging ≥ 21 years to ≤ 45.
• Patients undergoing cesarean section under spinal anesthesia.
• American Society of Anesthesiologists (ASA) physical statusphysical status classes II.

You may not qualify if:

• Patient's refusal of procedure or participation in the study.
• Coagulopathy and bleeding disorders.
• Use of chronic pain medications.
• Pregnancy-induced hypertension or diabetes.
• Evidence of Local skin infections at site of injection.
• Body mass index \>40kg/m2
• A history of relevant local anesthetic allergy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University faculty of medicine

Cairo, Egypt, Egypt

Location

Related Publications (1)

• Hassan, Shamsul Kamaruljan, et al. "Comparison of analgesic efficacy and safety of bupivacaine plus ketamine versus bupivacaine alone in rectus sheath block for midline laparotomy." Anaesthesia, Pain & Intensive Care 27.2 (2023): 154-160.

  BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• AHMED Ad Elgamal

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Ad MAHMOUD Ebrahim elgamal

CONTACT

+02 01159008254; AhmedElgamal@med.asu.edu.eg

Eman Sh Abdelmaqsoud

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 20, 2025
• Study Start: April 25, 2025
• Primary Completion: April 25, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-03

Locations

EG (1)