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

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ClinicalTrials.gov Identifier: NCT03956966
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
mohamed adel abdelrahman ahmed, Minia University

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.


Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: TQL block with saline Drug: TQL block with Bupivacaine Drug: TQL block with Bupivacaine and dexamethasone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double blind
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019


Arm Intervention/treatment
Placebo Comparator: saline
bilateral quadratus lumborum block using 0.9% normal saline
Drug: TQL block with saline

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

Other Name: C Group

Active Comparator: Bupivacaine
bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%
Drug: TQL block with Bupivacaine

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

Other Name: B Group

Active Comparator: Bupivacaine and dexamethasone
bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone
Drug: TQL block with Bupivacaine and dexamethasone

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

Other Name: D Group




Primary Outcome Measures :
  1. Time for first request to rescue analgesia [ Time Frame: 24 hours ]
    Time for the first request to rescue analgesia (in minutes)


Secondary Outcome Measures :
  1. postoperative Nalbuphine [ Time Frame: 24 hours after surgery ]
    Cumulative postoperative Nalbuphine consumption (total dose given in milligrams)

  2. intraoperative fentanyl [ Time Frame: For 4 hours after start of anaesthesia ]
    Cumulative intraoperative fentanyl consumption (total dose given in micrograms)

  3. Postoperative pain severity will be assessed using VAPS [ Time Frame: For 24 hours after surgery ]
    The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAPS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain

  4. side effects [ Time Frame: For 24 hours after surgery ]
    Incidence of postoperative nausea and vomiting



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956966


Contacts
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Contact: Haidy S Mansour, MD 01221802324 ext +2 haidy_mourad@yahoo.com
Contact: Mohmed S Abdelrahman, Dr 01000344985 ext +2 dr.ma55.ma@gmail.com

Locations
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Egypt
Minya University Recruiting
Minya, Egypt, 61519
Contact: haidy S Mansour, MD    01221802324 ext +2    haidy_mourad@yahoo.com   
Contact: mohamed A abdelrahman, Dr    01000344985 ext +2    dr.ma55.ma@gmail.com   
Sponsors and Collaborators
Minia University
Investigators
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Study Director: Haidy S Mansour, MD assistant professor of Anesthesia and Surgical Intensive Care

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Responsible Party: mohamed adel abdelrahman ahmed, principle investigator, Minia University
ClinicalTrials.gov Identifier: NCT03956966     History of Changes
Other Study ID Numbers: 88-11/2018
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mohamed adel abdelrahman ahmed, Minia University:
Quadratus Lumborum Block
Laparoscopic Cholecystectomy
dexamethasone
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents