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

Sponsor
Zealand University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04951752
Collaborator
(none)
307
Enrollment
1
Location
3.6
Anticipated Duration (Months)
85.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ropivacaine injection

Study Design

Study Type:
Observational
Actual Enrollment :
307 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Apr 14, 2021
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Duration of recovery [0-300 minutes]

      Minutes from arrival in PACU to completed recovery (arrival until ready for departure)

    Secondary Outcome Measures

    1. Total time spent in recovery [0-300 minutes]

      Minutes from arrival in PACU to actual departure time (arrival until actual departure)

    2. Duration of stay at PACU after completed recovery [0-300 minutes]

      Minutes from completed recovery to actual departure from PACU

    3. Total opioid consumption in PACU [0-300 minutes]

      Total amount of opioid administered, converted to Oral Morphine Equivalents

    4. Highest pain score in PACU [0-300 minutes]

      Highest reported Numeric Rating Scale of pain during stay in recovery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zealand University Hospital Roskilde Denmark 4000

    Sponsors and Collaborators

    • Zealand University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT04951752
    Other Study ID Numbers:
    • SOPRE-001
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ropivacaine

    Study Results

    No Results Posted as of Jul 7, 2021