NCT03328988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

3.3 years

First QC Date

May 5, 2017

Last Update Submit

January 3, 2022

Conditions

Postoperative PainChronic Pain Post-ProceduraalNausea and Vomiting, Postoperative

Keywords

bladder cancerradical cystectomyepidural analgesiaquadratus lumborum blockpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • opiate consumption

    intravenous patient controlled analgesia

    24 hours

Secondary Outcomes (6)

  • pain score

    7 days

  • postoperative nausea and vomiting

    72 hours

  • mobilisation

    72 hours after surgery

  • quality of life

    12 months

  • persistent pain

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Quadratus lumborum block

EXPERIMENTAL

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

Epidural

NO INTERVENTION

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

Interventions

QLBPROCEDURE

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

Also known as: quadratus lumborum block
Quadratus lumborum block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (3)

  • 1. Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki. 2. Witjes AJ, Lebret T, Comperat EM et al. Eur Urol. 2016 Jun 30 . 3. Azhar RA, Bochner B, Catto J et al. Eur Urol. 2016; 70: 176-187. 4. Voldby AW, Brandstrup B. Journal of Intensive Care 2016; 4:27. 5. Rawal N. Eur J Anae sthesiol 2016; 33:160 - 171 6. Kehlet H, Jensen TS, Woolf CJ . Lancet. 2006 May 13;367(9522):1618- 25 7. Gordon DB, de Leon-Casasola OA, Wu CL, ET AL. The Journal of Pain 2016; 17(2): 158-166. 8. Chou R, Gordon DB, de Leon-Casasola OA, ET AL. The Journal of Pain 2016;17(2):131-157 9. Gustavsson A., Bjorkman J., Ljungcrantz C., ET AL. Eur J Pain 2012:16 ; 289 - 299 10. Breivik H, Bang U, Jalonen J, ET AL Acta Anesthesiol Scand 20 10; 54: 16- 41. 11. Davies RG, Myles PS, Graham JM Br J Anaesth. 2006 Apr;96(4):418-26. 13. 12. Murouchi T, Iwasaki S, Yamakage M. Reg Anesth Pain Med. 2016;41:146 - 150. 13. Carney J, Finnerty O, Rauf J, ET AL. Anaesthesia. 2011;66:1023 - 30. 14. Blanco R, Ansari T, Riad W, Shetty N. Reg Anest Pain Med: Nov/Dec 2016 - vol 41 - p 757- 767. 15. Kenneth F Schulz, , Douglas G Altman, David Moher, BMJ 2010;340:c332 16. http://www.consort-statement.org

    BACKGROUND

  • Veskimae E, Korgvee A, Huhtala H, Koskinen H, Kalliomaki ML, Tammela T, Junttila E. Quadratus lumborum block is feasible alternative to epidural block for postoperative analgesia after open radical cystectomy: surgical and oncological outcomes of a randomised clinical trial. Scand J Urol. 2025 Mar 13;60:59-65. doi: 10.2340/sju.v60.43105.

    PMID: 40079670DERIVED

  • Korgvee A, Veskimae E, Huhtala H, Koskinen H, Tammela T, Junttila E, Kalliomaki ML. Posterior quadratus lumborum block versus epidural analgesia for postoperative pain management after open radical cystectomy: A randomized clinical trial. Acta Anaesthesiol Scand. 2023 Mar;67(3):347-355. doi: 10.1111/aas.14188. Epub 2023 Jan 3.

    PMID: 36547262DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomitingUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Maija-Liisa Kalliomaki, PhD

    Tampere University Hospital, Department of anesthesia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Patients are randomized and allocated in blocks of ten to either epidural of QLB group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

November 1, 2017

Study Start

April 27, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)