Postoperative PainPhase 4NCT03663478
Continuous TQL Block for Elective Cesarean Section
A Phase 4 study testing Ropivacaine and Saline in people with Postoperative Pain and Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Anesthesia, Local
- What is being tested?
- Ropivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Sep 2018to 8 Apr 2020
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age.
- Scheduled for elective Caesarean Section in spinal anaesthesia.
- Have received thorough information, verbally and in written, and signed the "Informed Consent" form on participation in the trial.
Who cannot join
- Inability to cooperate
- Inability to understand Danish
- Allergy to local anaesthetics or opioids
- Excessive daily intake of opioids, according to the discretion of the investigator
- Local infection at the site of injection or systemic infection
- Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.
The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.
- Conditions
- Postoperative Pain, Anesthesia, Local
- Being tested
- Ropivacaine, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour
SalineDrug
2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Ropivacaine Receives: Drug: Ropivacaine |
| Control | Placebo comparator | Isotonic saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first opioid
The time from catheters placement to the administration of opioids
Measured: 24 hours postoperatively
Secondary outcomes (6)
Pain intensity (NRS 0-10/10)
NRS (numeric rating scale) score in the study period at 3, 6, 9, 12 and 24 hours postoperatively. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the Patient-Controlled Analgesia (PCA) pump display prior to administration of the PCA boluses. NRS is a pain scale where the patient gives her pain a number from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 hours postoperatively
Total morphine consumption.
Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).
Measured: 24 hours
Catheter displacement.
Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).
Measured: 24 hours
Patient satisfaction with application of the catheters.
NRS 0-10/10 during placement of catheters
Measured: 24 hours
The degree of morphine-related side effects (PONV, itching, fatigue, etc.).
On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe.
Measured: 24 hours
Time from operation to ambulation.
Time from operation to ambulation.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start4 Sep 2018
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Børglum, MD PhD, Study chair, Zealand University Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663478
- Sponsor's protocol ID
- TQL Catheters
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steingrimsdottir GE, Hansen CK, Borglum J. Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial. Acta Anaesthesiol Scand. 2020 Sep;64(8):1218-1223. doi: 10.1111/aas.13601. Epub 2020 Apr 22.
PubMed 32270474
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT03663478
- Acronym / sponsor ID
- TQL Catheters
- Conditions
- Postoperative Pain, Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 10 Sep 2018 (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 aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: RopivacaineRopivacaine |
| Control | Placebo comparator | Drug: SalineIsotonic saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age.
- Scheduled for elective Caesarean Section in spinal anaesthesia.
- Have received thorough information, verbally and in written, and signed the "Informed Consent" form on participation in the trial.
Key exclusion criteria (6 listed)
- Inability to cooperate
- Inability to understand Danish
- Allergy to local anaesthetics or opioids
- Excessive daily intake of opioids, according to the discretion of the investigator
- Local infection at the site of injection or systemic infection
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 |
|---|---|---|
| Ropivacaine2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour | Drug | Intervention |
| Saline2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour | Drug | Control |
Primary outcome
Time to first opioid
Time frame: 24 hours postoperatively
The time from catheters placement to the administration of opioids
6 secondary outcomes
Pain intensity (NRS 0-10/10)
Time frame: 24 hours postoperatively
Total morphine consumption.
Time frame: 24 hours
Catheter displacement.
Time frame: 24 hours
Patient satisfaction with application of the catheters.
Time frame: 24 hours
The degree of morphine-related side effects (PONV, itching, fatigue, etc.).
Time frame: 24 hours
Time from operation to ambulation.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 32270474Steingrimsdottir GE, Hansen CK, Borglum J. Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial. Acta Anaesthesiol Scand. 2020 Sep;64(8):1218-1223. doi: 10.1111/aas.13601. Epub 2020 Apr 22.
- Individual participant dataSharing planned: No
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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, MD PhD study chair
Zealand University Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Saline in people with Postoperative Pain and 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first opioid (time frame: 24 hours postoperatively). 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 NCT03663478, which also lists 1 linked publication.
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 3 Mar 2021.