Skip to main content
OpenTrials
Completed

NCT Number: NCT03328988

QLB and Radical Cystectomy, Postoperative Pain

There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours.

Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.

44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Chronic Pain Post-Proceduraal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nausea Nausea and Vomiting, Postoperative Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural.

The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with bladder cancer coming to the open radical cystectomy.

Exclusion criteria

  • age under 18y or over 85y,
  • diabetes type 1 with complications,
  • no co-operation or inadequate finnish language,
  • persistent pain for other reason.

Treatment and study plan

QLB

Procedure

bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle

Other names: quadratus lumborum block

Primary outcomes

  1. opiate consumption

    Time frame: 24 hours

    intravenous patient controlled analgesia

Secondary outcomes

  1. pain score

    Time frame: 7 days

    numerical rating scale

  2. postoperative nausea and vomiting

    Time frame: 72 hours

    numerical rating scale and amount of vomites

  3. mobilisation

    Time frame: 72 hours after surgery

    standing up and mobilizing

  4. quality of life

    Time frame: 12 months

    SF 36

  5. persistent pain

    Time frame: 12 months

    paindetect McGill

  6. functional query

    Time frame: 12 months

    assessment how pain in operation region limits daily functions

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Comparing Two Different Analgesic Block Methods for Postoperative Pain and Recovery After Surgery -Quadratus Lumborum Block (QLB): the Effect on Peri- and Postoperative Pain and Recovery After Radical Cystectomy

Acronym: BladderQLB

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Nov 1, 2017
Registry last updated
Jan 4, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.