Clinical trial NCT03339284: QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery
Official title: Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Chronic Pain Post-Proceduraal
Nausea and Vomiting, Postoperative
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic.

Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.

Recently quadratus lumborum block (QLB) 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. A single shot QLB has reported to last up to 48 hours.

Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known.

90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.


Eligibility criteria: Inclusion Criteria:

* patients with renal cancer coming to the laparoscopic radical nephrectomy

Exclusion Criteria:

* age under 18y or over 85y
* diabetes type 1 with complications
* no co-operation or inadequate finnish language skills
* persistent pain for other reason
* severe hepatic insufficiency or paracetamol (acetaminophen) is contraindicated for other reason
* any type of steroid in regular use
* oxycodone contraindicated
* medications changing notably paracetamol (acetaminophen) and/or ropivacaine metabolism in regular use

Primary outcomes:
measure: opiate consumption
timeFrame: 24 hours
Secondary outcomes:
measure: opiate consumption
timeFrame: 72 hours
measure: postoperative nausea
timeFrame: 72 hours
measure: pain score
timeFrame: 7 days
measure: mobilization
timeFrame: 72 hours
measure: quality of life
timeFrame: 12 months
measure: persistent pain
timeFrame: 12 months
measure: functional query
timeFrame: 12 months
measure: postoperative vomiting
timeFrame: 72 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital, Department of Anesthesia
name: Maija Kalliomaki, PhD
role: PRINCIPAL_INVESTIGATOR
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