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Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block (TFBP) Phase 1 68

Not yet recruiting
Clinical Trial NCT06935669 (TFBP) is designed to study Supportive Care for Analgesia. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 25 April 2025 until the study accrues 68 participants. Led by Ain Shams University, this study is expected to complete by 15 May 2026. The latest data from ClinicalTrials.gov was last updated on 20 April 2025.
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.
Detailed Description
Cesarean section (CS) is one of the most common surgeries and usually causes moderate to severe pain for up to 48 h. The rate of CS, which is a life-saving surgical procedure in cases of certain complications that occur during pregnancy and birth, has exceeded 20% worldwide Pain control after CS has crucial importance, especially in the first 24 h, to facilitate early ambulation and the establishment of breastfeeding...Show More
Official Title

Randomised Controlled Clinical Trial Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block After Cesarean Section Under Spinal Anaesthesia

Conditions
Analgesia
Publications
Scientific articles and research papers published about this clinical trial:
  • 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.
Other Study IDs
  • TFBP
  • FMASU MD36/2025
NCT ID Number
NCT06935669
Start Date (Actual)
2025-04-25
Last Update Posted
2025-04-20
Completion Date (Estimated)
2026-05-15
Enrollment (Estimated)
68
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalKetamine and bupivacaine
Transversalis fascia plane block
Ketamine
Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.
Bupivacain
Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.
Active ComparatorBupivacaine alone
Transversalis fascia plane block
Bupivacaine
Control group to evaluate the additional effect of ketamine in the experimental arm.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time to first rescue analgesia will be recorded
Time (in minutes/hours) from the completion of the transversalis fascia plane block to the administration of the first dose of rescue analgesia will be recorded. Rescue analgesia will be given when the patient reports a VAS score ≥ 4 or requests additional pain relief. A longer time to first rescue analgesia in the ketamine + bupivacaine group would indicate prolonged analgesic duration compared to the bupivacaine-only group.
Day 1
total requirements of rescue analgesia Nalbuphine over the first 24 hours postoperative will be recorded
Rescue analgesia will be given when the patient reports a VAS score ≥ 4 or requests additional pain relief.
Day 1
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
21 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • Patients aging ≥ 21 years to ≤ 45.
  • Patients undergoing cesarean section under spinal anesthesia.
  • American Society of Anesthesiologists (ASA) physical statusphysical status classes II.

  • 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.
Ain Shams University logoAin Shams University344 active studies to explore
Study Central Contact
Contact: Ahmed Ad MAHMOUD Ebrahim elgamal, +02 01159008254, [email protected]
Contact: Eman Sh Abdelmaqsoud
1 Study Locations in 1 Countries

Egypt

Ain Shams University faculty of medicine, Cairo, Egypt, Egypt
Ain Shams University faculty of medicine Ain Shams Universit faculty of medicine, Contact, 02 26837673, [email protected]