One-Puncture Versus Multipoint Technique of Rectus Sheath Block with Transverse Abdominis Plane Block

Not Applicable

• Conditions: Laparoscopic Cholecystectomy

• Registration Number: NCT06599255
• Lead Sponsor: Zagazig University

Brief Summary

the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique

Detailed Description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture \"O\" group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.

In the Multipoint \"M \" group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.

In the Control \"C \" group (n=34 ): The patient will receive patient controlled analgesia\&;PCA\&

Study Timeline

• Study First Submitted: 2024-08-30
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-09-20
• Primary Completion: 2025-09-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Age: 18-45 years old.
• Sex: both sexes.
• Physical status: ASA I to III.
• Body mass index (BMI): 18- 30 kg/m2.
• Type of operations: elective laparoscopic cholecystectomy.
• Written informed consent from the patient.

Exclusion Criteria

• Known hypersensitivity to lidocaine or bupivacaine.
• Opioid-dependent patients.
• Coagulation disorders or taking drugs affect surgical hemostasis.
• Patients with pre-existing neurological deficits.
• Uncooperative patient or with altered mental status.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The total postoperative opioid consumption in the first 24 hours.	24 hours postoperative	opioid consumption

Secondary Outcome Measures

Name	Time	Method
The block performance time	up to 5 minutes	the time from the placement of the ultrasound probe on the patient's skin to the end of the local anesthetic injection
Onset of sensory block	up to 30 minutes	the time from the end of the injection of local anesthetic (bupivacaine) to the loss of pinprick sensation using a sterile 25-G needle in the operation field.
The Numerical Pain Rating Scale	24 hours postoperative	A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)
Patient satisfaction	24 hour postoperative	The patient satisfactionwill be assessed using the 7-point Likert-like verbal rating scale The patientwill be asked to express his satisfaction; 1. extremely dissatisfied.; 2. Dissatisfied.; 3. somewhat dissatisfied.; 4. unsatisfied.; 5. somewhat satisfied.; 6. Satisfied.; 7. extremely satisfied.

Trial Locations

Locations (1)

Faculty of Medicine,Zagazig University; 🇪🇬 Zagazig, Elsharkia,, Egypt,, Egypt