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

NCT04951752 | Unknown DMC

• 1 other identifier: SOPRE-001
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Duration of recovery

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

  0-300 minutes

Secondary Outcomes (4)

• Total time spent in recovery

  0-300 minutes

• Duration of stay at PACU after completed recovery

  0-300 minutes

• Total opioid consumption in PACU

  0-300 minutes

• Highest pain score in PACU

  0-300 minutes

Study Arms (10)

Hemicolectomy, Active treatment

2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block

Drug: Ropivacaine injection

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

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

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

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

Elective Caesarean section, Placebo treatment

2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block

Interventions

Ropivacaine injection DRUG

Transmuscular quadratus lumborum block - active

Also known as: Transmuscular quadratus lumborum block

Elective Caesarean section, Active treatment; Hemicolectomy, Active treatment; Hysterectomy, Active treatment; Nephrectomy, Active treatment; Percutaneous nephrolithotomy, Active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- Elective Surgery

You may not qualify if:

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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

Related Publications (3)

• 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: 33106280 BACKGROUND

• Hansen CK, Dam M, Steingrimsdottir GE, Laier GH, Lebech M, Poulsen TD, Chan VWS, Wolmarans M, Bendtsen TF, Borglum 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:rapm-2019-100540. doi: 10.1136/rapm-2019-100540. Online ahead of print.

  PMID: 31308263 BACKGROUND

• Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30.

  PMID: 31153628 RESULT

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jens Børglum Neimann, MD, PhD

  Associate Professor, Zealand University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: July 7, 2021
• Study Start: April 14, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-06

Locations

DK (1)