Clinical trial NCT05918796: Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia
Official title: Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post Operative Pain
Keywords: bupivacaine
dexamethasone
quadratus lumborum block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: measuring the time interval required till the first analgesic dose
timeFrame: the first 24 hours
Secondary outcomes:
measure: total pethidine dose received
timeFrame: total pethidine dose received in 24 hours
measure: mean blood pressure
timeFrame: 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.
measure: heart rate changes
timeFrame: 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.
measure: Incidence of side effects
timeFrame: record any side effect over 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
state: EL Abassia
Study officials:
affiliation: Faculty of medicine Ain Shams University
name: rasha g abusinna, MD
role: PRINCIPAL_INVESTIGATOR
References: