NCT03650998

Brief Summary

Study is designed to assess the effect of the transmuscular quadratus lumborum block on postoperative opioid consumption and pain for patients undergoing laparoscopic hysterectomy. Study is randomized, placebo-controlled and blinded. Seventy patients will be included.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Sep 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

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

August 27, 2018

Last Update Submit

January 9, 2020

Conditions

Postoperative Pain

Keywords

nerve blockultrasoundopioidshysterectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    How much cumulated opioid in oral morphine equivalents does the participant require/use.

    Twelve hours postoperatively

Secondary Outcomes (1)

  • Postoperative pain intensity

    12 hours.

Study Arms (2)

Active

ACTIVE COMPARATOR

Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0.375% single shot. In both arms morphine will be administered IV as part of a patient controlled analgesia PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

Drug: Ropivacaine

Placebo

PLACEBO COMPARATOR

Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL Saline single shot. In both arms morphine will be administered IV as part of a patient controlled analgesia PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

Drug: Saline

Interventions

RopivacaineDRUG

See arm description

Active
SalineDRUG

See arm description

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHysterectomy requires a uterus.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for TLH

You may not qualify if:

  • Inability to cooperate
  • Inability to speak, read and understand Danish
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids, according to the investigators decision
  • 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
  • Co-morbidity, ASA\>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital, Department of Anaesthesiology

Roskilde, Region Sjælland, 4000, Denmark

Location

Related Publications (1)

  • Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.

    PMID: 33082286DERIVED

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 Officials

  • Jens Borglum, Ph.D.; MD

    Consultant, associate professor.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

September 28, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 13, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)