Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2019-10-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, placebo-controlled, randomised

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Solution used for block (local anesthetic or placebo) is known to anesthetist not involved in patient's care.

Study Groups

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QLB with 0,375% ropivacaine

Group Type EXPERIMENTAL

Qadratus Lumborum Block

Intervention Type PROCEDURE

Bilateral, ultrasound - guided Quadratus Lumborum Block

30 milliliters of 0.375% Ropivacaine

Intervention Type DRUG

30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block

QLB with 0,9% NaCl

Group Type PLACEBO_COMPARATOR

Qadratus Lumborum Block

Intervention Type PROCEDURE

Bilateral, ultrasound - guided Quadratus Lumborum Block

30 milliliters of 0.9% NaCl

Intervention Type DRUG

30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block

Interventions

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Qadratus Lumborum Block

Bilateral, ultrasound - guided Quadratus Lumborum Block

Intervention Type PROCEDURE

30 milliliters of 0.375% Ropivacaine

30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block

Intervention Type DRUG

30 milliliters of 0.9% NaCl

30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No