NCT03571490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

June 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

October 27, 2017

Last Update Submit

March 18, 2020

Conditions

Postoperative PainUltrasound Guided Transmuscular Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

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

    12 hours postoperatively

Secondary Outcomes (13)

  • opioid consumption

    6 hours postoperatively

  • opioid consumption

    18 hours postoperatively

  • opioid consumption

    24 hours postoperatively

  • NRS score

    12 hours postoperatively

  • NRS score at rest and activity

    6 hours postoperatively

  • +8 more secondary outcomes

Study Arms (2)

TQL Ropivacaine(active)

ACTIVE COMPARATOR

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

Drug: Ropivacaine

TQL saline (placebo)

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

RopivacaineDRUG

Single shot of ropivacaine 0.325%

TQL Ropivacaine(active)
SalineDRUG

Single shot of saline 0.9%

TQL saline (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand university Hospital, Anaesthesiology

Roskilde, 4000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33106280DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Double blind placebo Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

June 27, 2018

Study Start

June 26, 2018

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

DK(1)