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

M

medina medical center

Status

Completed

Conditions

Post Operative Analgesia
Laparoscopic Cholecystectomy
Ultrasound Guided
Quadratus Lumborum

Treatments

Drug: Bilateral QL block
Drug: Intraperitoneal and port sites infiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT06721039
MS 168/2022

Details and patient eligibility

About

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.

Full 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).

Enrollment

70 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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%).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Group 1
Active Comparator group
Description:
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
Treatment:
Drug: Bilateral QL block
Group 2
Active Comparator group
Description:
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
Treatment:
Drug: Intraperitoneal and port sites infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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