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Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03600129
Enrollment
50
Registered
2018-07-26
Start date
2018-07-25
Completion date
2019-10-21
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

regional anesthesia, quadratus lumborum block, patient controlled anesthesia, laparoscopic prostatectomy

Brief 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.

Interventions

PROCEDUREQadratus Lumborum Block

Bilateral, ultrasound - guided Quadratus Lumborum Block

DRUG30 milliliters of 0.375% Ropivacaine

30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block

DRUG30 milliliters of 0.9% NaCl

30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

Double blind, placebo-controlled, randomised

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumption following prostatectomy24 hoursOxycodone consumption with Patient-Controlled Analgesia pump

Secondary

MeasureTime frameDescription
Pain score24 hoursPain 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.
Time to first dose of opioid24 hoursTime in minutes from emergence from anesthesia to the first request for opioid
Opioids - related complications24 hoursThe occurence of symptoms and conditions related to the use of opioids, like nausea, ileus, itching

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026