QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

Phase 4

• Conditions: Postoperative Pain; Chronic Pain Post-Proceduraal; Nausea and Vomiting, Postoperative
• Interventions: Drug: Dexamethasone sodium phosphate; Drug: Sodium Chloride 9mg/mL; Drug: Ropivacaine Hydrocloride

• Registration Number: NCT03339284
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Study Start: 2017-12-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-23
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLB without dexamethasone	Sodium Chloride 9mg/mL	Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml
Placebo	Sodium Chloride 9mg/mL	Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml
QLB with dexamethasone	Ropivacaine Hydrocloride	Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml
QLB without dexamethasone	Ropivacaine Hydrocloride	Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml
QLB with dexamethasone	Dexamethasone sodium phosphate	Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml

Primary Outcome Measures

Name	Time	Method
opiate consumption	24 hours	cumulative opiate consumption postoperatively

Secondary Outcome Measures

Name	Time	Method
opiate consumption	72 hours	cumulative opiate consumption postoperatively
postoperative nausea	72 hours	numerical rating scale
pain score	7 days	numerical rating scale
persistent pain	12 months	paindetect McGill
functional query	12 months	assessment how pain in operation region limits daily functions
quality of life	12 months	SF36 query
mobilization	72 hours	time to standing up and mobilizing after surgery
postoperative vomiting	72 hours	amount of vomites

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland