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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956966
Enrollment
90
Registered
2019-05-21
Start date
2018-11-20
Completion date
2020-09-01
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

Quadratus Lumborum Block, Laparoscopic Cholecystectomy, dexamethasone

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.

Interventions

DRUGTQL 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

DRUGTQL 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

DRUGTQL 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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

randomized, double blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time for first request to rescue analgesia24 hoursTime for the first request to rescue analgesia (in minutes)

Secondary

MeasureTime frameDescription
intraoperative fentanylFor 4 hours after start of anaesthesiaCumulative intraoperative fentanyl consumption (total dose given in micrograms)
Postoperative pain severity will be assessed using VAPSFor 24 hours after surgeryThe 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
side effectsFor 24 hours after surgeryIncidence of postoperative nausea and vomiting
postoperative Nalbuphine24 hours after surgeryCumulative postoperative Nalbuphine consumption (total dose given in milligrams)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026