Anesthesia, LocalTQL_PACUNCT04951752
Effect of the Transmuscular Quadratus Lumborum Block on Duration of Stay in Recovery
An observational study of Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- How many people
- 307 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Apr 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery (hemicolectomy, nephrectomy, percutaneous nephrolithiotomy, hysterectomy of caesarean section).
Who may be able to join
- Elective Surgery
Who cannot join
- Inability to cooperate
- Allergy to local anaesthetics or opioids
- Inability to understand Danish
- Regular intake of opioids
- Local infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Ropivacaine injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Also called Transmuscular quadratus lumborum block
Transmuscular quadratus lumborum block - active
| Study group | Role | What they receive |
|---|---|---|
| Hemicolectomy, Active treatment | 2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Ropivacaine injection | |
| Elective Caesarean section, Placebo treatment | 2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of recovery
Minutes from arrival in PACU to completed recovery (arrival until ready for departure)
Measured: 0-300 minutes
Secondary outcomes (4)
Total time spent in recovery
Minutes from arrival in PACU to actual departure time (arrival until actual departure)
Measured: 0-300 minutes
Duration of stay at PACU after completed recovery
Minutes from completed recovery to actual departure from PACU
Measured: 0-300 minutes
Total opioid consumption in PACU
Total amount of opioid administered, converted to Oral Morphine Equivalents
Measured: 0-300 minutes
Highest pain score in PACU
Highest reported Numeric Rating Scale of pain during stay in recovery
Measured: 0-300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start14 Apr 2021
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Børglum Neimann, MD, PhD, Study director, Associate Professor, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951752
- Sponsor's protocol ID
- SOPRE-001
- Acronym
- TQL_PACU
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request
Publications
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.
PubMed 33106280Hansen 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.
PubMed 31308263Dam 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.
PubMed 31153628
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04951752
- Acronym / sponsor ID
- TQL_PACU / SOPRE-001
- Conditions
- Anesthesia, Local
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Hemicolectomy, Active treatment | – | Drug: Ropivacaine injection2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block |
| Hemicolectomy, Placebo treatment | – | –2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block |
| Nephrectomy, Active treatment | – | Drug: Ropivacaine injection2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block |
| Nephrectomy, Placebo treatment | – | –2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block |
| Percutaneous nephrolithotomy, Active treatment | – | Drug: Ropivacaine injection1x30mL 0.75% Ropivacaine administered by way of transmuscular quadratus lumborum block |
| Percutaneous nephrolithotomy, Placebo treatment | – | –1x30mL isotonic saline administered by way of transmuscular quadratus lumborum block |
| Hysterectomy, Active treatment | – | Drug: Ropivacaine injection2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block |
| Hysterectomy, Placebo treatment | – | –2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block |
| Elective Caesarean section, Active treatment | – | Drug: Ropivacaine injection2x30mL 0.375% Ropivacaine administered by way of transmuscular quadratus lumborum block |
| Elective Caesarean section, Placebo treatment | – | –2x30mL isotonic saline administered by way of transmuscular quadratus lumborum block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery (hemicolectomy, nephrectomy, percutaneous nephrolithiotomy, hysterectomy of caesarean section).
Key inclusion criteria (1 listed)
- Elective Surgery
Key exclusion criteria (5 listed)
- Inability to cooperate
- Allergy to local anaesthetics or opioids
- Inability to understand Danish
- Regular intake of opioids
- Local infection at site of injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine injectionAlso: Transmuscular quadratus lumborum blockTransmuscular quadratus lumborum block - active | Drug | Elective Caesarean section, Active treatment, Hemicolectomy, Active treatment, Hysterectomy, Active treatment, Nephrectomy, Active treatment, Percutaneous nephrolithotomy, Active treatment |
Primary outcome
Duration of recovery
Time frame: 0-300 minutes
Minutes from arrival in PACU to completed recovery (arrival until ready for departure)
4 secondary outcomes
Total time spent in recovery
Time frame: 0-300 minutes
Duration of stay at PACU after completed recovery
Time frame: 0-300 minutes
Total opioid consumption in PACU
Time frame: 0-300 minutes
Highest pain score in PACU
Time frame: 0-300 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Background: PubMed 33106280Dam 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.
- Background: PubMed 31308263Hansen 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.
- Results publication: PubMed 31153628Dam 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.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Børglum Neimann, MD, PhD study director
Associate Professor, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of recovery (time frame: 0-300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04951752, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.