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Completed

NCT Number: NCT03308955

Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

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.

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Key information

Conditions

Cholecystectomy Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Bursa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tramadol

Drug

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.

ultrasound guided quadratus lumborum block

Procedure

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.

Ultrasound guided placebo Quadratus Lumborum block

Procedure

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.

Primary outcomes

  1. Visual Analog Pain Scale

    Time frame: Postoperative 24 hours

    Visual Analog Pain Scale was used for pain

Secondary outcomes

  1. tramadol consumption

    Time frame: Postoperative 24 hours

    tramadol consumption

  2. side effect profile scores)

    Time frame: Postoperative 24 hour

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

  3. additional analgesic use

    Time frame: Postoperative 24 hour

    additional analgesic use

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Analgesic Effect of Ultrasound Guided Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2017
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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