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

Primary Purpose

Postoperative Pain, Ultrasound Guided Transmuscular Quadratus Lumborum Block

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zealand university Hospital, Anaesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TQL Ropivacaine(active)

TQL saline (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

opioid consumption
Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2017
Last Updated
March 18, 2020
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03571490
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Ultrasound Guided Transmuscular Quadratus Lumborum Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Double blind placebo Controlled Trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TQL Ropivacaine(active)
Arm Type
Active Comparator
Arm Description
Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine
Arm Title
TQL saline (placebo)
Arm Type
Placebo Comparator
Arm Description
Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Single shot of ropivacaine 0.325%
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Single shot of saline 0.9%
Primary Outcome Measure Information:
Title
opioid consumption
Description
Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).
Time Frame
12 hours postoperatively
Secondary Outcome Measure Information:
Title
opioid consumption
Description
Opioid consumption postoperatively (data from PCA pump and patient medical record).
Time Frame
6 hours postoperatively
Title
opioid consumption
Description
Opioid consumption postoperatively (data from PCA pump and patient medical record).
Time Frame
18 hours postoperatively
Title
opioid consumption
Description
Opioid consumption postoperatively (data from PCA pump and patient medical record).
Time Frame
24 hours postoperatively
Title
NRS score
Description
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity
Time Frame
12 hours postoperatively
Title
NRS score at rest and activity
Description
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Time Frame
6 hours postoperatively
Title
NRS score at rest and activity
Description
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Time Frame
18 hours postoperatively
Title
NRS score at rest and activity
Description
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Time Frame
24 hours postoperatively
Title
Opioid-related side effects
Description
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Time Frame
6 hours postoperatively
Title
Opioid-related side effects
Description
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Time Frame
12 hours postoperatively
Title
Opioid-related side effects
Description
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Time Frame
18 hours postoperatively
Title
Opioid-related side effects
Description
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Time Frame
24 hours postoperatively
Title
Patient satisfaction with application of the block. NRS
Description
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Time Frame
Immediately after application of the block
Title
Ambulation
Description
Time from operation to ambulation
Time Frame
within 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Zealand university Hospital, Anaesthesiology
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33106280
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.
Results Reference
derived

Learn more about this trial

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

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