QLB and Radical Cystectomy, Postoperative Pain

Postoperative Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328988
• Other study ID #: R17008
• Status: Completed
• Phase: N/A
• Start date: April 27, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opiate consumption	intravenous patient controlled analgesia	24 hours
Secondary	pain score	numerical rating scale	7 days
Secondary	postoperative nausea and vomiting	numerical rating scale and amount of vomites	72 hours
Secondary	mobilisation	standing up and mobilizing	72 hours after surgery
Secondary	quality of life	SF 36	12 months
Secondary	persistent pain	paindetect McGill	12 months
Secondary	functional query	assessment how pain in operation region limits daily functions	12 months