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

NCT ID: NCT03571490

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Ultrasound Guided Transmuscular Quadratus Lumborum Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Double blind placebo Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double blind

Study Groups

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TQL Ropivacaine(active)

Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Single shot of ropivacaine 0.325%

TQL saline (placebo)

Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Single shot of saline 0.9%

Interventions

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Ropivacaine

Single shot of ropivacaine 0.325%

Intervention Type DRUG

Saline

Single shot of saline 0.9%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zealand university Hospital, Anaesthesiology

Roskilde, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33106280 (View on PubMed)

Other Identifiers

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2017-002130-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V2.02.05.2017

Identifier Type: -

Identifier Source: org_study_id

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