Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy

NCT03956966 | Completed

• 1 other identifier: 88-11/2018
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

Quadratus Lumborum Block; Laparoscopic Cholecystectomy; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Time for first request to rescue analgesia

  Time for the first request to rescue analgesia (in minutes)

  24 hours

Secondary Outcomes (4)

• postoperative Nalbuphine

  24 hours after surgery

• intraoperative fentanyl

  For 4 hours after start of anaesthesia

• Postoperative pain severity will be assessed using VAPS

  For 24 hours after surgery

• side effects

  For 24 hours after surgery

Study Arms (3)

saline

PLACEBO COMPARATOR

bilateral quadratus lumborum block using 0.9% normal saline

Drug: TQL block with saline

Bupivacaine

ACTIVE COMPARATOR

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%

Drug: TQL block with Bupivacaine

Bupivacaine and dexamethasone

ACTIVE COMPARATOR

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone

Drug: TQL block with Bupivacaine and dexamethasone

Interventions

TQL block with saline DRUG

drug: saline 21 ml 0.9% normal saline administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours. Drug: Ketorolac analgesia In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than3. Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block, ultrasound-guided

Also known as: C Group

saline

TQL block with Bupivacaine DRUG

Drug: saline 1mL 0.9% normal saline administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Drug: Paracetamol 15 mg.kg will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given to all cases every 8 hours. Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3. Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block

Also known as: B Group

Bupivacaine

TQL block with Bupivacaine and dexamethasone DRUG

Drug: dexamethasone 1 mL dexamethasone "4mg" administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in MBP or HR of more than 20% of baseline for longer than 5 minutes. Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours. Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3. Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block

Also known as: D Group

Bupivacaine and dexamethasone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Physical Status I or II
• Elective laparoscopic Cholecystectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minya University

Minya, 61519, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride; Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Haidy S Mansour, MD

  assistant professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: randomized, double blind

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 21, 2019
• Study Start: November 20, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

EG (1)