Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308955
• Other study ID #: 2011-KAEK-25 2017-13/69
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: December 27, 2017
• Start date: August 22, 2017
• Est. completion date: December 2, 2017

Study information

• Verified date: December 2017
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2, 2017
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystectomy
• Nerve Block
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Tramadol
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.

Procedure:
• Ultrasound 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.
• Ultrasound 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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale	Visual Analog Pain Scale was used for pain	Postoperative 24 hours
Secondary	tramadol consumption	tramadol consumption	Postoperative 24 hours
Secondary	side effect profile scores)	side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)	Postoperative 24 hour
Secondary	additional analgesic use	additional analgesic use	Postoperative 24 hour