- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817916
Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery
May 6, 2024 updated by: Sakarya University
Comparison of Erector Spina Plane Block and Lumbar Plexus Block for Postoperative Analgesia in Femoral Fracture Surgery
The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications.
İn patients for femur fracture surgery.
The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures?
2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
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
-
-
-
Sakarya, Turkey
- Sakarya 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Proximal femoral surgery
- All patients who can respond to pain assessment questions
Exclusion Criteria:
- Regional block contraindications,
- Severe cardiac and respiratory disease,
- Severe coagulopathy,
- Body mass index greater than 35
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ESP Block
|
ESP block: ultrasound guided erector spina plane block
|
Active Comparator: LP block
|
LP block: ultrasound guided lumbar plexus block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption
Time Frame: postoperative 24 hours
|
Opioid consumption will be measured in micrograms.
|
postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Badiola I, Liu J, Huang S, Kelly JD 4th, Elkassabany N. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:26-29. doi: 10.1016/j.jclinane.2018.05.012. Epub 2018 Jun 1.
- Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
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 (Actual)
April 15, 2023
Primary Completion (Actual)
October 15, 2023
Study Completion (Actual)
November 15, 2023
Study Registration Dates
First Submitted
January 23, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ali eman 002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Femur Fracture
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Orthofix s.r.l.RecruitingPertrochanteric Fracture of Femur | Intertrochanteric Fracture of Femur | Subtrochanteric Fracture of FemurItaly
-
University of FloridaRecruitingDistal Femur FractureUnited States
-
AO Clinical Investigation and Publishing DocumentationActive, not recruitingDistal Femur FractureUnited States, Switzerland
-
Nationwide Children's HospitalTerminated
-
Ilocos Training and Regional Medical CenterUnknownIntertrochanteric Fractures | Pertrochanteric Fracture | Pertrochanteric Fracture of Femur, Closed | Pertrochanteric Fracture of Femur, Open
-
University of Alabama at BirminghamCompletedSupracondylar Femur FractureUnited States
-
Hadassah Medical OrganizationUnknownProximal Femur FractureIsrael
-
Amr Gamaleldin Mahmoud Khalil GendyaCompletedGeriatrics | Distal Femur FractureEgypt
-
University Health Network, TorontoRecruiting
-
Children's Hospital Los AngelesPediatric Orthopaedic Society of North AmericaActive, not recruiting
Clinical Trials on ESP block
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University of TriesteCliniche Humanitas Gavazzeni; A.O.U. Città della Salute e della Scienza - Molinette...UnknownPain, Postoperative | SAP Block Versus ESP Block | Evaluation of Locoregional Techniques | Multimodal Pain ManagementItaly
-
Ain Shams UniversityNot yet recruiting
-
Huazhong University of Science and TechnologyRecruitingPain, Acute | Nerve Block | Thoracic AnesthesiaChina
-
Ataturk UniversityNot yet recruitingPain, Acute | Opioid Use
-
Anna UskovaWithdrawnPain, PostoperativeUnited States
-
Assiut UniversityNot yet recruiting
-
Indonesia UniversityCompletedChronic Post Operative Pain | Laparoscopy | Kidney Transplant; Complications | Anesthesia RegionalIndonesia
-
Azienda Ospedaliera SS. Antonio e Biagio e Cesare...Enrolling by invitationBreast Cancer | Breast Neoplasms | Breast CarcinomaItaly