Clinical trial NCT03956966: Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy
Official title: Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: Quadratus Lumborum Block
Laparoscopic Cholecystectomy
dexamethasone
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double blind
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.

Because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.

Detailed description: The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side.

The following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.

Eligibility criteria: Inclusion Criteria:

* American Physical Status I or II
* Elective laparoscopic Cholecystectomy

Exclusion Criteria:

* Patient refusal.
* Hematological diseases
* Bleeding disorders.
* Coagulation abnormality.
* Psychiatric diseases.
* Local skin infection
* Sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Emergency laparoscopic cholecystectomy
* If laparoscopic procedure converted to open.

Primary outcomes:
measure: Time for first request to rescue analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative Nalbuphine
timeFrame: 24 hours after surgery
measure: intraoperative fentanyl
timeFrame: For 4 hours after start of anaesthesia
measure: Postoperative pain severity will be assessed using VAPS
timeFrame: For 24 hours after surgery
measure: side effects
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya University
Study officials:
affiliation: assistant professor of Anesthesia and Surgical Intensive Care
name: Haidy S Mansour, MD
role: STUDY_DIRECTOR
References: