BladderQLB: QLB and Radical Cystectomy, Postoperative Pain

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03328988

Collaborator

(none)

Enrollment

Location

Arms

52.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Chronic Pain Post-Proceduraal Nausea and Vomiting, Postoperative	Procedure: QLB	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized controlled studyProspective 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 :

Apr 27, 2017

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

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 Names: 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

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 Names:

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

Outcome Measures

Primary Outcome Measures

opiate consumption [24 hours]
intravenous patient controlled analgesia

Secondary Outcome Measures

pain score [7 days]
numerical rating scale
postoperative nausea and vomiting [72 hours]
numerical rating scale and amount of vomites
mobilisation [72 hours after surgery]
standing up and mobilizing
quality of life [12 months]
SF 36
persistent pain [12 months]
paindetect McGill
functional query [12 months]
assessment how pain in operation region limits daily functions