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

NCT ID: NCT06721039

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-03
• Study Completion Date: 2023-03-08

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.

Detailed Description

Since the concept of day case surgeries is getting more popular, surgeons and anesthesiologists are trying their best to provide adequate post-operative analgesia. The proper management of post-operative pain ensures early ambulation of patients and obviates many post-operative complications.

The most common modality for post-operative pain management has remained the parenteral use of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids.

Intraperitoneal and periportal infiltration with local anesthetic agents has also remained a popular method to take care of immediate postoperative pain. This technique is virtually cost-free, rapid, and hardly requires any special technical experience or equipment for its use. But as there are advances in anesthetic techniques, more and more regional blocks are being tried to take care of post-operative pain. The choice of anaesthetic block technique depends upon the site of surgical incision proposed.

Quadratus lumborum (QL) block is a posterior abdominal wall block which permits the spread of local anesthetic agent behind the quadratus lumborum muscle into a triangular space known as a lumbar interfacial triangle, which lies beside the middle layer of the thoracolumbar fascia.

This interfacial plane is in adjoining proximity with numerous sympathetic fibers and conjoin with the thoracic paravertebral space, thus preceding to a long-standing block with the capability to provide visceral analgesia (Kadam, 2013).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

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

Group Type: ACTIVE_COMPARATOR

Bilateral QL block

Intervention Type: 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 2

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

Group Type: ACTIVE_COMPARATOR

Intraperitoneal and port sites infiltration

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• • 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%).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

medina medical center

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Gamal Salah Elsawy

lecturere of anaesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Azhar University Faculty of Medicine

New Damietta, , Egypt

Countries

Egypt

Other Identifiers

MS 168/2022

Identifier Type: -

Identifier Source: org_study_id