- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328988
QLB and Radical Cystectomy, Postoperative Pain (BladderQLB)
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
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tampere, Finland, 33521
- Tampere University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
|
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Other Names:
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
opiate consumption
Time Frame: 24 hours
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intravenous patient controlled analgesia
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24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain score
Time Frame: 7 days
|
numerical rating scale
|
7 days
|
postoperative nausea and vomiting
Time Frame: 72 hours
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numerical rating scale and amount of vomites
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72 hours
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mobilisation
Time Frame: 72 hours after surgery
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standing up and mobilizing
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72 hours after surgery
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quality of life
Time Frame: 12 months
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SF 36
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12 months
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persistent pain
Time Frame: 12 months
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paindetect McGill
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12 months
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functional query
Time Frame: 12 months
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assessment how pain in operation region limits daily functions
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12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maija-Liisa Kalliomaki, PhD, Tampere University Hospital, Department of Anesthesia
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R17008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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