QLB and Radical Cystectomy, Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Patients are randomized and allocated in blocks of ten to either epidural of QLB group

Study Groups

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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.

Group Type EXPERIMENTAL

QLB

Intervention Type PROCEDURE

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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QLB

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

Intervention Type PROCEDURE

Other Intervention Names

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quadratus lumborum block

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No