QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

Sponsor

Tampere University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03339284

Collaborator

(none)

Enrollment

Location

Arms

66.8

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Chronic Pain Post-Proceduraal Nausea and Vomiting, Postoperative	Drug: Dexamethasone sodium phosphate Drug: Ropivacaine Hydrocloride Drug: Sodium Chloride 9mg/mL	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Primary Purpose:

Treatment

Official Title:

Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy

Actual Study Start Date :

Dec 4, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: QLB with dexamethasone Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml	Drug: Dexamethasone sodium phosphate Dexamethasone injection Other Names: Oradexon Drug: Ropivacaine Hydrocloride Ropivacaine injection
Active Comparator: QLB without dexamethasone Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml	Drug: Ropivacaine Hydrocloride Ropivacaine injection Drug: Sodium Chloride 9mg/mL Sodium Chloride injection Other Names: Saline
Placebo Comparator: Placebo Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml	Drug: Sodium Chloride 9mg/mL Sodium Chloride injection Other Names: Saline

Arm

Intervention/Treatment

Active Comparator: QLB with dexamethasone

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

Drug: Dexamethasone sodium phosphate

Dexamethasone injection

Other Names:

Oradexon

Drug: Ropivacaine Hydrocloride

Ropivacaine injection

Active Comparator: QLB without dexamethasone

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

Drug: Ropivacaine Hydrocloride

Ropivacaine injection

Drug: Sodium Chloride 9mg/mL

Sodium Chloride injection

Other Names:

Saline

Placebo Comparator: Placebo

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

Drug: Sodium Chloride 9mg/mL

Sodium Chloride injection

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

opiate consumption [24 hours]
cumulative opiate consumption postoperatively

Secondary Outcome Measures

opiate consumption [72 hours]
cumulative opiate consumption postoperatively
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
quality of life [12 months]
SF36 query
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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