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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04951752
Other study ID # SOPRE-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 14, 2021
Est. completion date August 1, 2021

Study information

Verified date June 2021
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 307
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Ropivacaine injection
Transmuscular quadratus lumborum block - active

Locations

Country Name City State
Denmark Zealand University Hospital Roskilde

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Børglum 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. — View Citation

Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Børglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single c — View Citation

Hansen CK, Dam M, Steingrimsdottir GE, Laier GH, Lebech M, Poulsen TD, Chan VWS, Wolmarans M, Bendtsen TF, Børglum J. Ultrasound-guided transmuscular quadratus lumborum block for elective cesarean section significantly reduces postoperative opioid consumption and prolongs time to first opioid request: a double-blind randomized trial. Reg Anesth Pain Med. 2019 Jul 14. pii: rapm-2019-100540. doi: 10.1136/rapm-2019-100540. [Epub ahead of print] — View Citation

Outcome

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