Clinical trial NCT03571490: Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy
Official title: Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Ultrasound Guided Transmuscular Quadratus Lumborum Block
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Double blind placebo Controlled Trial
Primary purpose: TREATMENT

Brief summary: Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.


Eligibility criteria: Inclusion Criteria:

* over 18 years
* Kidney cancer
* Have received thorough information, orally and in written
* Signed the "Informed Consent" form on participation in the trial

Exclusion Criteria:

* Inability to cooperate
* Inability to speak and understand Danish both orally and written
* Allergy to local anaesthetics or opioids
* Daily intake of opioids
* Local infection at the site of injection or systemic infection
* Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
* Known abuse of alcohol or medicine
* Pregnancy

Primary outcomes:
measure: opioid consumption
timeFrame: 12 hours postoperatively
Secondary outcomes:
measure: opioid consumption
timeFrame: 6 hours postoperatively
measure: opioid consumption
timeFrame: 18 hours postoperatively
measure: opioid consumption
timeFrame: 24 hours postoperatively
measure: NRS score
timeFrame: 12 hours postoperatively
measure: NRS score at rest and activity
timeFrame: 6 hours postoperatively
measure: NRS score at rest and activity
timeFrame: 18 hours postoperatively
measure: NRS score at rest and activity
timeFrame: 24 hours postoperatively
measure: Opioid-related side effects
timeFrame: 6 hours postoperatively
measure: Opioid-related side effects
timeFrame: 12 hours postoperatively
measure: Opioid-related side effects
timeFrame: 18 hours postoperatively
measure: Opioid-related side effects
timeFrame: 24 hours postoperatively
measure: Patient satisfaction with application of the block. NRS
timeFrame: Immediately after application of the block
measure: Ambulation
timeFrame: within 24 hours postoperatively
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand university Hospital, Anaesthesiology
Study officials:
References:
citation: Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy. Reg Anesth Pain Med. 2021 Jan;46(1):18-24. doi: 10.1136/rapm-2020-101745. Epub 2020 Oct 26.