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CompletedNCT03308955Updated Dec 29, 2017

Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

An interventional study of Tramadol and Ultrasound guided Quadratus Lumborum block in Cholecystectomy, Postoperative Pain and Nerve Block, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure has become the treatment of choice for many patients with symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain, despite a multimodal analgesic regime.

This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.

02

Conditions studied

  • Cholecystectomy
  • Postoperative Pain
  • Nerve Block

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03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Grup B

    Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

    Drug: Tramadol · Procedure: Ultrasound guided Quadratus Lumborum block

  • Sham comparator
    Grup S

    Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

    Drug: Tramadol · Procedure: Ultrasound guided placebo Quadratus Lumborum block

Interventions

  • DrugTramadol

    400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

  • ProcedureUltrasound guided Quadratus Lumborum block

    Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

  • ProcedureUltrasound guided placebo Quadratus Lumborum block

    Ultrasound guided placebo Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

05

What researchers measure

Primary outcomes

  1. Visual Analog Pain Scale

    Visual Analog Pain Scale was used for pain

    Time frame: Postoperative 24 hours

Secondary outcomes

  1. tramadol consumption

    tramadol consumption

    Time frame: Postoperative 24 hours

  2. side effect profile scores)

    side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)

    Time frame: Postoperative 24 hour

  3. additional analgesic use

    additional analgesic use

    Time frame: Postoperative 24 hour

06

Study locations

1 site
  • University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
    Bursa, Turkey
07

Registry details

Key details

Study ID
NCT03308955
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Korgün Ökmen (Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Oct 13, 2017
Start date
Aug 22, 2017
Primary completion
Aug 22, 2017
Completion
Dec 2, 2017
Last update
Dec 29, 2017

Study contacts

Korgün Ökmen, M.D
principal investigator · UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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