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

NCT06599255 | Enrolling By Invitation

• 1 other identifier: ZU-IRB#568/27-AUG-2024
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• The total postoperative opioid consumption in the first 24 hours.

  opioid consumption

  24 hours postoperative

Secondary Outcomes (4)

• The block performance time

  up to 5 minutes

• Onset of sensory block

  up to 30 minutes

• The Numerical Pain Rating Scale

  24 hours postoperative

• Patient satisfaction

  24 hour postoperative

Study Arms (3)

one puncture

ACTIVE COMPARATOR

one-puncture technique of RSB combined with TAPB.

Procedure: US-guided RSB and TAPB by one-puncture technique.

Multipoint

ACTIVE COMPARATOR

multipoint technique of RSB combined with TAPB.

Procedure: multipont

control

NO INTERVENTION

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.

Interventions

US-guided RSB and TAPB by one-puncture technique. PROCEDURE

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

one puncture

multipont PROCEDURE

, 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.

Multipoint

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, Elsharkia,, Egypt,, 44519, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: September 10, 2025
• Study Completion: December 10, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)