Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Ultrasound Guided Transmuscular Quadratus Lumborum Block
• Intervention / Treatment: Drug: Ropivacaine; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Zealand university Hospital, Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TQL Ropivacaine(active); Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine	Drug: Ropivacaine; Single shot of ropivacaine 0.325%
Placebo Comparator: TQL saline (placebo); Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%	Drug: Saline; Single shot of saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).	12 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	Opioid consumption postoperatively (data from PCA pump and patient medical record).	6 hours postoperatively
opioid consumption	Opioid consumption postoperatively (data from PCA pump and patient medical record).	18 hours postoperatively
opioid consumption	Opioid consumption postoperatively (data from PCA pump and patient medical record).	24 hours postoperatively
NRS score	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity	12 hours postoperatively
NRS score at rest and activity	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	6 hours postoperatively
NRS score at rest and activity	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	18 hours postoperatively
NRS score at rest and activity	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	24 hours postoperatively
Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	6 hours postoperatively
Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	12 hours postoperatively
Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	18 hours postoperatively
Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	24 hours postoperatively
Patient satisfaction with application of the block. NRS	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	Immediately after application of the block
Ambulation	Time from operation to ambulation	within 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: V2.02.05.2017; 2017-002130-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No