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QLB and Radical Cystectomy, Postoperative Pain (BladderQLB)

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ClinicalTrials.gov Identifier: NCT03328988
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

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 disease Intervention/treatment Phase
Postoperative Pain Chronic Pain Post-Proceduraal Nausea and Vomiting, Postoperative Procedure: QLB Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
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 : April 27, 2017
Estimated Primary Completion Date : April 27, 2020
Estimated Study Completion Date : April 27, 2020

Resource links provided by the National Library of Medicine


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.
Procedure: QLB
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
Other Name: 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




Primary Outcome Measures :
  1. opiate consumption [ Time Frame: 24 hours ]
    intravenous patient controlled analgesia


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328988


Contacts
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Contact: Maija-Liisa Kalliomaki, PhD +358331169424 maija-liisa.kalliomaki@pshp.fi
Contact: Andrus Korgvee, MD +358331169617 andrus.korgvee@pshp.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Maija-Liisa Kalliomaki, PhD    +358331169424    maija-liisa.kalliomaki@pshp.fi   
Contact: Eija Junttila, PhD    +358331166001    eija.junttila@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Study Director: Maija-Liisa Kalliomaki, PhD Tampere University Hospital, Department of anesthesia

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

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03328988     History of Changes
Other Study ID Numbers: R17008
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tampere University Hospital:
bladder cancer
radical cystectomy
epidural analgesia
quadratus lumborum block
postoperative pain

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Pain, Postoperative
Chronic Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive