Effect of the Transmuscular Quadratus Lumborum Block on Duration of Stay in Recovery (TQL_PACU)

June 29, 2021 updated by: Zealand University Hospital

Effect of the Transmuscular Quadratus Lumborum Block on Duration of Stay in Recovery: a Single-centre, Retrospective, Observational Study Based on Five Selected Randomised Controlled Trials

The study will review data collected in 5 previously completed randomised controlled trials with a new primary outcome: to assess whether administration of the transmuscular quadratus lumborum block has an impact on the time an individual patient stays in the postanaesthesia care unit and how much opioid is consumed during this specified time.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective surgery (hemicolectomy, nephrectomy, percutaneous nephrolithiotomy, hysterectomy of caesarean section).

Description

Inclusion Criteria:

- Elective Surgery

Exclusion Criteria:

  • Inability to cooperate
  • Allergy to local anaesthetics or opioids
  • Inability to understand Danish
  • Regular intake of opioids
  • Local infection at site of injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemicolectomy, Active treatment
2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block
Drug: Ropivacaine injection
Transmuscular quadratus lumborum block - active
Other Names:
  • Transmuscular quadratus lumborum block
Hemicolectomy, Placebo treatment
2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block
Nephrectomy, Active treatment
2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block
Drug: Ropivacaine injection
Transmuscular quadratus lumborum block - active
Other Names:
  • Transmuscular quadratus lumborum block
Nephrectomy, Placebo treatment
2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block
Percutaneous nephrolithotomy, Active treatment
1x30mL 0.75% Ropivacaine administered by way of transmuscular quadratus lumborum block
Drug: Ropivacaine injection
Transmuscular quadratus lumborum block - active
Other Names:
  • Transmuscular quadratus lumborum block
Percutaneous nephrolithotomy, Placebo treatment
1x30mL isotonic saline administered by way of transmuscular quadratus lumborum block
Hysterectomy, Active treatment
2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block
Drug: Ropivacaine injection
Transmuscular quadratus lumborum block - active
Other Names:
  • Transmuscular quadratus lumborum block
Hysterectomy, Placebo treatment
2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block
Elective Caesarean section, Active treatment
2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block
Drug: Ropivacaine injection
Transmuscular quadratus lumborum block - active
Other Names:
  • Transmuscular quadratus lumborum block
Elective Caesarean section, Placebo treatment
2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of recovery
Time Frame: 0-300 minutes
Minutes from arrival in PACU to completed recovery (arrival until ready for departure)
0-300 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time spent in recovery
Time Frame: 0-300 minutes
Minutes from arrival in PACU to actual departure time (arrival until actual departure)
0-300 minutes
Duration of stay at PACU after completed recovery
Time Frame: 0-300 minutes
Minutes from completed recovery to actual departure from PACU
0-300 minutes
Total opioid consumption in PACU
Time Frame: 0-300 minutes
Total amount of opioid administered, converted to Oral Morphine Equivalents
0-300 minutes
Highest pain score in PACU
Time Frame: 0-300 minutes
Highest reported Numeric Rating Scale of pain during stay in recovery
0-300 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Study Director: Jens Børglum Neimann, MD, PhD, Associate Professor, Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOPRE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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