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QLB and Radical Cystectomy, Postoperative Pain (BladderQLB)

Primary Purpose

Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
QLB
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring bladder cancer, radical cystectomy, epidural analgesia, quadratus lumborum block, postoperative pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Quadratus lumborum block

Epidural

Arm Description

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.

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

Outcomes

Primary Outcome Measures

opiate consumption
intravenous patient controlled analgesia

Secondary Outcome Measures

pain score
numerical rating scale
postoperative nausea and vomiting
numerical rating scale and amount of vomites
mobilisation
standing up and mobilizing
quality of life
SF 36
persistent pain
paindetect McGill
functional query
assessment how pain in operation region limits daily functions

Full Information

First Posted
May 5, 2017
Last Updated
January 3, 2022
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03328988
Brief Title
QLB and Radical Cystectomy, Postoperative Pain
Acronym
BladderQLB
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative
Keywords
bladder cancer, radical cystectomy, epidural analgesia, quadratus lumborum block, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled study
Masking
None (Open Label)
Masking Description
Patients are randomized and allocated in blocks of ten to either epidural of QLB group
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadratus lumborum block
Arm Type
Experimental
Arm Description
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.
Arm Title
Epidural
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
QLB
Other Intervention Name(s)
quadratus lumborum block
Intervention Description
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Primary Outcome Measure Information:
Title
opiate consumption
Description
intravenous patient controlled analgesia
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
pain score
Description
numerical rating scale
Time Frame
7 days
Title
postoperative nausea and vomiting
Description
numerical rating scale and amount of vomites
Time Frame
72 hours
Title
mobilisation
Description
standing up and mobilizing
Time Frame
72 hours after surgery
Title
quality of life
Description
SF 36
Time Frame
12 months
Title
persistent pain
Description
paindetect McGill
Time Frame
12 months
Title
functional query
Description
assessment how pain in operation region limits daily functions
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maija-Liisa Kalliomaki, PhD
Organizational Affiliation
Tampere University Hospital, Department of anesthesia
Official's Role
Study Director
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
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QLB and Radical Cystectomy, Postoperative Pain

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