QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

Tampere University Hospital

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Chronic Pain Post-Proceduraal; Nausea and Vomiting, Postoperative

Treatments: Drug: Sodium Chloride 9mg/mL; Drug: Dexamethasone sodium phosphate; Drug: Ropivacaine Hydrocloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03339284

R17103M

2017-002254-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

QLB with dexamethasone

Active Comparator group

Description:

Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml

Treatment:

Drug: Ropivacaine Hydrocloride

Drug: Dexamethasone sodium phosphate

QLB without dexamethasone

Active Comparator group

Description:

Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml

Treatment:

Drug: Ropivacaine Hydrocloride

Drug: Sodium Chloride 9mg/mL

Placebo

Placebo Comparator group

Description:

Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml

Treatment:

Drug: Sodium Chloride 9mg/mL