Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative
Conditions
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.
Interventions
DRUGDexamethasone sodium phosphate
Dexamethasone injection
Ropivacaine injection
Sodium Chloride injection
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients are randomized and allocated in blocks of nine to either placebo or QLB with dexamethasone or QLB without dexamethasone group
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| opiate consumption | 24 hours | cumulative opiate consumption postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea | 72 hours | numerical rating scale |
| pain score | 7 days | numerical rating scale |
| mobilization | 72 hours | time to standing up and mobilizing after surgery |
| opiate consumption | 72 hours | cumulative opiate consumption postoperatively |
| persistent pain | 12 months | paindetect McGill |
| functional query | 12 months | assessment how pain in operation region limits daily functions |
| postoperative vomiting | 72 hours | amount of vomites |
| quality of life | 12 months | SF36 query |
Countries
Finland
Contacts
Primary ContactEija Junttila, PhD
Backup ContactAndrus Korgvee, MD
Outcome results
None listed