Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

Prostate Cancer Clinical Trial

Official title:

Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600129
• Other study ID #: 83/PB/2018
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: October 21, 2019

Study information

• Verified date: October 2019
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA status less or equal 3

• Scheduled for transperitoneal or extraperitoneal endoscopic prostatectomy

• Able to understand information provided and to sign the informed consent for participation in the study

Exclusion Criteria:

• known allergy to local anesthetics and opioids

• infection in the area of block placement

• known chronic use of opioids, gabapentinoids and tricyclic antidepressants

• mental inability to understand the principles and rules of patient-controlled analgesia pump

Related Conditions & MeSH terms

• Pain, Postoperative
• Prostate Cancer

Intervention

Procedure:
• Qadratus Lumborum Block
Bilateral, ultrasound - guided Quadratus Lumborum Block

Drug:
• 30 milliliters of 0.375% Ropivacaine
30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block
• 30 milliliters of 0.9% NaCl
30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block

Locations

Country	Name	City	State
Poland	Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption following prostatectomy	Oxycodone consumption with Patient-Controlled Analgesia pump	24 hours
Secondary	Pain score	Pain scores assessed with Numeric Rating Scale (NRS).In this scale pain intensity is expressed using one of the numbers 0 - 10, 0 being no pain and 10 worst pain imaginable.	24 hours
Secondary	Time to first dose of opioid	Time in minutes from emergence from anesthesia to the first request for opioid	24 hours
Secondary	Opioids - related complications	The occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching	24 hours