Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block Versus Intraperitoneal and Periportal Bupivacaine Infiltration in Postoperative Analgesia After Laparoscopic Cholecystectomy

NCT06721039 | Completed

• 1 other identifier: MS 168/2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The primary outcome: is measured by pain at rest and upon mobilization according to VAS. VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.

Conditions

Quadratus Lumborum; Laparoscopic Cholecystectomy; Ultrasound Guided; Post Operative Analgesia

Keywords

Quadratus Lumborum Plane Block, Intraperitoneal and Periportal Bupivacaine Infiltration, Post Operative Analgesia, Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• pain score postoperative

  24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Bilateral QL block: sonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes

Drug: Bilateral QL block

Group 2

ACTIVE COMPARATOR

Intraperitoneal and port sites infiltration with 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes

Drug: Intraperitoneal and port sites infiltration

Interventions

Bilateral QL block DRUG

sonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes

Group 1

Intraperitoneal and port sites infiltration DRUG

with 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes

Group 2

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-60 years of both sexes.
• Elective laparoscopic cholecystectomy under general anesthesia.
• Physical Status: ASA I and II patients after taking written and informed consent.

You may not qualify if:

• Refusal of procedure or participation in the study by patients.
• Physical status: ASA III or above.
• Infection at site of injection.
• Psychiatric illness that leads to inability to cooperate, speak or read.
• Daily use of opioids.
• History or evidence of coagulopathy especially if INR\>1.5 and platelet \<100.000
• Allergies to drugs used (Bupivacaine 0.5%).

Sponsors & Collaborators

• medina medical center: lead

Study Sites (1)

Al-Azhar University Faculty of Medicine

New Damietta, Egypt

Location

MeSH Terms

Interventions

Infusions, Parenteral

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturere of anaesthesia and intensive care

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: April 3, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 8, 2023
• Last Updated: December 6, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)