Postoperative PainNCT02036749
Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery
A study testing nerve block in people with Postoperative Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics close to the anterior border of the quadratus lumborum muscle. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with cesarean delivery
- American Society of Anesthesiologists classification (ASA) < 3
- adequate communication skills
- Body mass index < 32
Who cannot join
- ASA > 2
- chronic pain
- neurological illness/ neuropathy
- contraindication against local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized, controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after cesarean delivery will be compared with a placebo control group of 20 patients to investigate analgesic consumption, pain level, opioid related side effects and mobilization.
- Conditions
- Postoperative Pain
- Being tested
- nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve blockProcedure or surgery
Also called quadratus lumborum block
quadratus lumborum block
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum block (nerve block) | Active comparator | quadratus lumborum block with ropivacaine Receives: Procedure: nerve block |
| sham block | Placebo comparator | QL block with saline Receives: Procedure: nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Measured: 48 hours
Secondary outcomes (1)
pain level (NRS)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Krohg, Oslo University Hospital
- Investigators
- Anders Krohg, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036749
- Sponsor's protocol ID
- 2013/1293
- Status last verified
- Oct 2015
- First submitted
- 13 Jan 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02036749
- Acronym / sponsor ID
- 2013/1293
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jan 2014 (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.
The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized, controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after cesarean delivery will be compared with a placebo control group of 20 patients to investigate analgesic consumption, pain level, opioid related side effects and mobilization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum block (nerve block) | Active comparator | Procedure: nerve blockquadratus lumborum block with ropivacaine |
| sham block | Placebo comparator | Procedure: nerve blockQL block with saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with cesarean delivery
- American Society of Anesthesiologists classification (ASA) < 3
- adequate communication skills
- Body mass index < 32
Key exclusion criteria (4 listed)
- ASA > 2
- chronic pain
- neurological illness/ neuropathy
- contraindication against local anesthetics
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 |
|---|---|---|
| nerve blockAlso: quadratus lumborum blockquadratus lumborum block | Procedure or surgery | quadratus lumborum block (nerve block), sham block |
Primary outcome
morphine consumption
Time frame: 48 hours
1 secondary outcome
pain level (NRS)
Time frame: 48 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 7 Oct 2015.
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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.
Anders Krohg, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve block in people with Postoperative Pain, run by Oslo University Hospital 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 4 inclusion and 4 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 7 Oct 2015. 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.
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?
morphine consumption (time frame: 48 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 7 Oct 2015.