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

NCT ID: NCT06935669

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2026-05-15

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. Insufficient analgesia in the postoperative period may cause a number of undesirable effects, such as patient discomfort, thromboembolism due to extended immobilization, and increased pulmonary secretions resulting in complications The well-known side effects of analgesic morphine as nausea, vomiting, itching and sedation, may interfere with the interaction between mother and child, breastfeeding and post-partum experience in a dose-dependent manner. However, a number of alternative strategies have been described in order to reduce morphine consumption post-operatively .

The mode and type of analgesia should be safe and effective. A stimulus caused by a lesion in tissue or organs during surgery is the cause of postoperative pain .

The primary source of pain after abdominal surgeries, including CS, are the anterior abdominal wall and abdominal viscera, and blocking these areas could provide proper postoperative analgesia .

Recently, the application of fascial plane blocks has increased due to the widespread use of ultrasound among anesthesiologists and the avoidance of opioids in a multimodal analgesic strategy. Different regional anesthetic techniques have been introduced, including ilioinguinal nerve blocks, abdominal field blocks, Transversalis Fascia Plane (TFP) blocks, and Transversus Abdominis Plane (TAP) blocks to alleviate pain from the abdominal wall incision .

Transversalis Fascia Plane, performed in the posterior axillary line, blocks branches of L1 nerve roots, including ilioinguinal and iliohypogastric nerves. This method has been used to control postoperative pain in patients undergoing different lower abdominal surgeries A variety of anesthetic agents such as bupivacaine, levobupivacaine, and ropivacaine are commonly used in TAP blocks. These drugs provide short-term analgesia and primarily alleviate somatic pain. To extend the duration of analgesic efficacy, various adjuvants such as opioids, ketamine, clonidine, and alpha-2 agonists like dexmedetomidine have been added .

Bupivacaine is one of the widely used local analgesics. ketamine affects pain modulation through multiple mechanisms of action. It is a non-competitive N-methyl-d-aspartate (NMDA) receptor antagonist, which exerts an anti-hyperalgesic effect by decreasing central sensitization and reducing the wind-up phenomenon in the postoperative period .

The aim of this study is to investigate the effect of transversalis fascia plane block using bupivacaine plus ketamine on postoperative pain compared to bupivacaine alone in patients undergoing cesarean section under spinal anaesthesia.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ketamine and bupivacaine

Transversalis fascia plane block

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Bupivacain

Intervention Type: DRUG

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

Bupivacaine alone

Transversalis fascia plane block

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Bupivacain

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

Intervention Type: DRUG

Other Intervention Names

Ketalar; Marcaine; Marcaine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AHMED Ad Elgamal

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University faculty of medicine

Cairo, Egypt, Egypt

Countries

Egypt

Central Contacts

Ahmed Ad MAHMOUD Ebrahim elgamal

Role: CONTACT

AhmedElgamal@med.asu.edu.eg

+02 01159008254

Eman Sh Abdelmaqsoud

Role: CONTACT

Facility Contacts

Ain Shams University faculty of medicine Ain Shams Universit faculty of medicine

Role: primary

dr.ahmedadel1999@gmail.com

02 26837673

References

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.

Reference Type: BACKGROUND

Other Identifiers

FMASU MD36/2025

Identifier Type: -

Identifier Source: org_study_id