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

One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block for Analgesia After Laparoscopic Cholecystectomy

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Procedure: US-guided RSB and TAPB by one-puncture technique.; Procedure: multipont

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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elsharkia,, Egypt,
    • Zagazig, Elsharkia,, Egypt,, Egypt, 44519
      • Faculty of Medicine,Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: one puncture; one-puncture technique of RSB combined with TAPB.	Procedure: US-guided RSB and TAPB by one-puncture technique.; The probe will be positioned transversely in the midline of the abdomen, between the xiphoid process and the umbilicus, revealing the linea alba. It was then moved outward along the costal margin, demonstrating the rectus abdominis overlapping the transverse abdominis. A 22-gauge, 120-mm ultrasound-visible block needle will be inserted from the inner side . Under direct vision, we will reach the posterior rectus abdominis sheath and pierced the anterior layer of the posterior sheath. Saline was injected to adjust its position. After that, 15 mL of 0.25% bupivacaine will be administered (aspiration was performed for every 5 mL injection), and we will observe the local anesthetic spreading inward . Then, the needle will break through the posterior layer of the tendon, and saline will be injected to confirm the needle's placement in the transversus abdominis plane. After confirming the tip placement, 15 mL of 0.25% bupivacaine will be slowly injected. The needle tip will be advanced al
Active Comparator: Multipoint; multipoint technique of RSB combined with TAPB.	Procedure: multipont; , the probe will be moved outward along the costal margin until the external oblique muscle, internal oblique muscle, and transverse abdominis muscle will be visible [9]. The needle will be inserted in-plane until the tip was positioned in the plane between the internal oblique muscle and the transverse abdominis muscle. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution. For the RSB, the same technique will be done as one puncture technique. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution.
No Intervention: control; nalbuphine (2 mg/kg) and normal saline to a total volume of 150 mL, with a background infusion rate of 2 mL/h, a bolus dose of 2 mL, a lockout interval of 15 min, and a maximum limit of 10 mL within 1 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total postoperative opioid consumption in the first 24 hours.	opioid consumption	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The block performance time	the time from the placement of the ultrasound probe on the patient's skin to the end of the local anesthetic injection	up to 5 minutes
Onset of sensory block	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.	up to 30 minutes
The Numerical Pain Rating Scale	A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)	24 hours postoperative
Patient satisfaction	The patient satisfactionwill be assessed using the 7-point Likert-like verbal rating scale The patientwill be asked to express his satisfaction; extremely dissatisfied.; Dissatisfied.; somewhat dissatisfied.; unsatisfied.; somewhat satisfied.; Satisfied.; extremely satisfied.	24 hour postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): September 10, 2025
• Study Completion (Estimated): December 10, 2025

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZU-IRB#568/27-AUG-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No