BladderQLB: QLB and Radical Cystectomy, Postoperative Pain

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03328988
Collaborator
(none)
41
Enrollment
1
Location
2
Arms
52.1
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: QLB
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized controlled studyProspective randomized controlled study
Masking:
None (Open Label)
Masking Description:
Patients are randomized and allocated in blocks of ten to either epidural of QLB group
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Apr 27, 2017
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Quadratus lumborum block

Single shot bilateral QLB, ropivacaine 75 mg (20 mL) per side, placed under ultrasound control, at the end of surgery. 22 patients will be allocated in this group.

Procedure: QLB
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Other Names:
  • quadratus lumborum block
  • No Intervention: Epidural

    Epidural catheter (placed before anesthesia induction), ropivacaine 75 mg in 50 mL isotonic saline (1,5 mg/mL), induction bolus after surgery 1 mL/10 kg ideal weight and there on continuous infusion 2-8 mL/h according to analgesic need. 22 patients will be allocated in this group. This is the current standard for postoperative pain relief in cystectomy patients in our hospital

    Outcome Measures

    Primary Outcome Measures

    1. opiate consumption [24 hours]

      intravenous patient controlled analgesia

    Secondary Outcome Measures

    1. pain score [7 days]

      numerical rating scale

    2. postoperative nausea and vomiting [72 hours]

      numerical rating scale and amount of vomites

    3. mobilisation [72 hours after surgery]

      standing up and mobilizing

    4. quality of life [12 months]

      SF 36

    5. persistent pain [12 months]

      paindetect McGill

    6. functional query [12 months]

      assessment how pain in operation region limits daily functions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Tampere University HospitalTampereFinland33521

    Sponsors and Collaborators

    • Tampere University Hospital

    Investigators

    • Study Director: Maija-Liisa Kalliomaki, PhD, Tampere University Hospital, Department of anesthesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tampere University Hospital
    ClinicalTrials.gov Identifier:
    NCT03328988
    Other Study ID Numbers:
    • R17008
    First Posted:
    Nov 1, 2017
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tampere University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2022