- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02036749
Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery
October 6, 2015 updated by: Anders Krohg, Oslo University Hospital
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 Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0023
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with cesarean delivery
- American Society of Anesthesiologists classification (ASA) < 3
- adequate communication skills
- Body mass index < 32
Exclusion Criteria:
- ASA > 2
- chronic pain
- neurological illness/ neuropathy
- contraindication against local anesthetics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: quadratus lumborum block (nerve block)
quadratus lumborum block with ropivacaine
|
quadratus lumborum block
Other Names:
|
|
Placebo Comparator: sham block
QL block with saline
|
quadratus lumborum block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
morphine consumption
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pain level (NRS)
Time Frame: 48 hours
|
48 hours
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
time to mobilization
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anders Krohg, MD, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
January 13, 2014
First Submitted That Met QC Criteria
January 14, 2014
First Posted (Estimate)
January 15, 2014
Study Record Updates
Last Update Posted (Estimate)
October 7, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/1293
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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