Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

Study Overview
=================
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.

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

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br>ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally. | Drug: Bupivacaine<br>* 18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block<br>|
| Active Comparator: bupivacaine and dexamethasone<br>ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally. | Drug: Bupivacaine<br>* 18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block<br>Drug: Dexamethasone<br>* dexamethasone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring the time interval required till the first analgesic dose | to reach a numeric rating scale NRS Pain score ≥4 | the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total pethidine dose received | record total dose of pethidine | total pethidine dose received in 24 hours | 
| mean blood pressure | hemodynamics | 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. | 
| heart rate changes | hemodynamics | 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. | 
| Incidence of side effects | occurrence of nausea and vomiting | record any side effect over 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexamethasone, quadratus lumborum block, bupivacaine