Pain, PostoperativePhase 4NCT02949778
Quadratus Lumborum Block for Abdominoplasty
A Phase 4 study testing QL-block, Ropivacaine and Sodium Chloride in people with Pain, Postoperative and Abdominoplasty, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Postoperative, Abdominoplasty
- What is being tested?
- QL-block, Ropivacaine and Sodium Chloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 7 Nov 2016to 13 Dec 2017
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists Physical Classification Status (ASA) I-II
- Age 18 to 64
- Weight above or equal to 60 kg
- Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
- Patient is expected able to cooperate during the treatment and follow up.
- Signed informed consent obtained and documented according to the International Conference on Harmonization (ICH) good clinical practice (GCP), and national/local regulations.
Who cannot join
- A history of anaphylactic shock
- Cardiovascular disease other than hypertension and/or hyperlipidemia
- Known allergy to ropivacaine or morphine
- A history of chronic pain
- Psychiatric comorbidity
- Scheduled opioid pain medication or neuroleptic drugs
Show all 10Show fewer
- Coagulation disorders or treatment with platelet inhibitors
- Pregnancy or breastfeeding
- Treatment with class III antiarrhythmics, sertindole, ziprasidone, amisulpride, ceritinib, hydroxyzine, fluvoxamine
- Any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial
Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.
- Conditions
- Pain, Postoperative, Abdominoplasty
- Being tested
- QL-block, Ropivacaine, Sodium Chloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL-blockProcedure or surgery
Also called Quadratus lumborum block
Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied
RopivacaineDrug
Also called Naropin
Ropivacaine 3.75mg/ml administered in QL-block as active treatment
Sodium ChlorideDrug
Sodium chloride 9mg/mL administered in QL-Block as placebo
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 3.75mg/mL | Active comparator | QL-block using 20 mL ropivacaine 3.75mg/mL Receives: Procedure: QL-block; Drug: Ropivacaine |
| Sodium chloride 9 mg/mL | Placebo comparator | QL-block using 20 mL sterile sodium chloride 9 mg/mL Receives: Procedure: QL-block; Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
total opioid consumption the first 24 postoperative hours
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 posted31 Oct 2016 (estimated)
- Study start7 Nov 2016
- Primary completion15 Jun 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thor Wilhelm Bjelland, MD, PhD, Principal investigator, Vestre Viken HT, Baerum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949778
- Sponsor's protocol ID
- BS-AIO-2015-QL-block
- Status last verified
- Dec 2017
- First submitted
- 25 Oct 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Requires approval by ethics committee and second consent form.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02949778
- Acronym / sponsor ID
- BS-AIO-2015-QL-block
- Conditions
- Pain, Postoperative, Abdominoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.
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 |
|---|---|---|
| Ropivacaine 3.75mg/mL | Active comparator | Procedure: QL-block, Drug: RopivacaineQL-block using 20 mL ropivacaine 3.75mg/mL |
| Sodium chloride 9 mg/mL | Placebo comparator | Procedure: QL-block, Drug: Sodium ChlorideQL-block using 20 mL sterile sodium chloride 9 mg/mL |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists Physical Classification Status (ASA) I-II
- Age 18 to 64
- Weight above or equal to 60 kg
- Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
- Patient is expected able to cooperate during the treatment and follow up.
Key exclusion criteria (10 listed)
- A history of anaphylactic shock
- Cardiovascular disease other than hypertension and/or hyperlipidemia
- Known allergy to ropivacaine or morphine
- A history of chronic pain
- Psychiatric comorbidity
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 |
|---|---|---|
| QL-blockAlso: Quadratus lumborum blockBilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied | Procedure or surgery | Ropivacaine 3.75mg/mL, Sodium chloride 9 mg/mL |
| RopivacaineAlso: NaropinRopivacaine 3.75mg/ml administered in QL-block as active treatment | Drug | Ropivacaine 3.75mg/mL |
| Sodium ChlorideSodium chloride 9mg/mL administered in QL-Block as placebo | Drug | Sodium chloride 9 mg/mL |
Primary outcome
Opioid consumption
Time frame: 24 hours
total opioid consumption the first 24 postoperative 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 19 Dec 2017.
- Individual participant dataSharing planned: No. Requires approval by ethics committee and second consent form.
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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.
Thor Wilhelm Bjelland, MD, PhD principal investigator
Vestre Viken HT, Baerum Hospital
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 QL-block, Ropivacaine and Sodium Chloride in people with Pain, Postoperative and Abdominoplasty, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 6 inclusion and 10 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 19 Dec 2017. 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 Norway. 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?
Opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.