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Completed

NCT Number: NCT05918796

Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

The objective of this study is to assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University Hospital

Cairo, EL Abassia, 11591, Egypt

About this study

Background: The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L2 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers.

Objective: To assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.

Patients and Methods: Sixty patients scheduled for elective Laparoscopic cholecystectomy surgeries under general anesthesia were included in this study, they were divided into two groups. Group A (perineural dexamethasone and bupivacaine group) [n=30] Those cases will receive 2ml volume of dexamethasone (8mg) combined with 18 ml of bupivacaine of 0.25% concentration. Group B (perineural bupivacaine group) [n=30] Those cases will receive perineural 18 ml bupivacaine (0.25%) combined with 2 ml normal saline.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aging > 18 years of both sexes.
  • Patients undergoing Laparoscopic cholecystectomy surgeries (duration of operation 50-80 minutes).
  • ASA physical status classes I - II.

Exclusion criteria

  • Patient's refusal of procedure or participation in the study.
  • ASA classes III or above.
  • Coagulopathy and bleeding disorders.
  • Local skin infections
  • Body mass index >40kg/m2

Treatment and study plan

Bupivacaine

Drug

18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block

Dexamethasone

Drug

dexamethasone

Primary outcomes

  1. measuring the time interval required till the first analgesic dose

    Time frame: the first 24 hours

    to reach a numeric rating scale NRS Pain score ≥4

Secondary outcomes

  1. total pethidine dose received

    Time frame: total pethidine dose received in 24 hours

    record total dose of pethidine

  2. mean blood pressure

    Time frame: will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.

    hemodynamics

  3. heart rate changes

    Time frame: will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.

    hemodynamics

  4. Incidence of side effects

    Time frame: record any side effect over 24 hours

    occurrence of nausea and vomiting

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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