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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: TQL block with saline
* Drug: TQL block with Bupivacaine
* Drug: TQL block with Bupivacaine and dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double blind
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>bilateral quadratus lumborum block using 0.9% normal saline | Drug: TQL block with saline<br>* 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<br>* Other names: C Group;|
| Active Comparator: Bupivacaine<br>bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% | Drug: TQL block with Bupivacaine<br>* 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<br>* Other names: B Group;|
| Active Comparator: Bupivacaine and dexamethasone<br>bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone | Drug: TQL block with Bupivacaine and dexamethasone<br>* 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<br>* Other names: D Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for first request to rescue analgesia | Time for the first request to rescue analgesia (in minutes) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative Nalbuphine | Cumulative postoperative Nalbuphine consumption (total dose given in milligrams) | 24 hours after surgery | 
| intraoperative fentanyl | Cumulative intraoperative fentanyl consumption (total dose given in micrograms) | For 4 hours after start of anaesthesia | 
| Postoperative pain severity will be assessed using VAPS | 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 | For 24 hours after surgery | 
| side effects | Incidence of postoperative nausea and vomiting | For 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, Quadratus Lumborum Block, Laparoscopic Cholecystectomy