- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427238
Pericapsular Nerve Group Block Added to Intra-articular Corticosteroid Injection in the Treatment of Hip Pain (PENGandIAI)
The Effect of Pericapsular Nerve Group Block Added to Intra-articular Corticosteroid Injection in the Treatment of Hip Pain Due to Osteoarthritis: An Observational Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this observational study, we will obtain information on the treatment response of patients who previously underwent hip joint injections guided by ultrasound and PENG block in addition to joint injections for hip pain unresponsive to medical treatment, as well as information that we believe may affect treatment response, such as patient age, gender, and disease duration, by reviewing patient files. The patients' treatment response will be evaluated according to the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis (WOMAC) index scores, and the pain scores obtained from the patient records before the procedure and one month, three months, and six months after the procedure will be compared. When examining patients for treatment success, the treatment outcomes of patients who received only intra-articular injections will be compared with those who received intra-articular injections + PENG blocks. Current evidence shows that intra-articular steroid injections provide symptomatic relief in hip OA and are recommended for non-surgical treatment. During the procedure, the patient is placed supine, and following sterile cleaning and draping, the ultrasound probe is placed transversely over the inguinal region. After visualizing the femoral head and femoral artery, vein, and nerve, local anesthesia with 1% lidocaine is applied to the needle insertion site after visualizing the femoral head and neck junction and the articular cartilage. Then, a 22-gauge, 100-mm needle is advanced toward the joint capsule, targeting the junction of the femoral neck and femoral head.After reaching the target area, 2 ml of dexamethasone and 2 ml of 0.025% bupivacaine are injected into the joint.
The pericapular nerve group (PENG) block is a treatment applied to block sensory nerve branches, including the articular branches of the femoral nerve, obturator nerve, and accessory obturator nerve that innervate the anterior joint capsule, and is frequently used in our clinic in conjunction with joint injection for hip pain. During the procedure, the patient is placed supine, and following sterile cleaning and draping, the anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE) are visualized using a convex ultrasound probe. The target for the PENG block is the musculo-fascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. After applying local anesthesia to the skin with 1% lidocaine, a 22-gauge, 100 mm needle is inserted and 2 ml of dexamethasone and 2 ml of 0.025% bupivacaine are injected into the target area. Patients are monitored for possible complications.
The primary objective of our study is to compare the treatment responses of patients diagnosed with hip OA who have undergone hip intra-articular injection and/or PENG block therapy and to investigate the effect of PENG block added to intra-articular injection on pain and functionality. The secondary objective is to evaluate other parameters (age, gender, disease duration, analgesic use, etc.) that may influence treatment outcomes at 6 months. The study protocol was approved by the local ethics committee, and the study was conducted in accordance with the principles of the Declaration of Helsinki.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06010
- Ezgi Can
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with hip pain due to hip osteoarthritis who have undergone hip intra-articular steroid + local anesthetic injection and/or PENG block under ultrasound guidance for this reason
- Persistence of pain for more than 6 months
- Failure of pain treatment with conservative methods
Exclusion Criteria:
- Those with inflammatory rheumatic joint disease (rheumatoid arthritis, gout, pseudogout, metabolic joint diseases),
- History of major trauma, hip surgery
- Cognitive dysfunction, history of psychiatric illness
- Hepatic or renal insufficiency
- Local or systemic infection
- Coagulopathy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intra-articular injection
During hip intra-articular injection, the patient is placed supine, and following sterile cleaning and draping, the ultrasound probe is placed transversely in the inguinal region.
After visualizing the femoral head and femoral artery, vein, and nerve, local anesthesia with 1% lidocaine is applied to the needle entry site after visualizing the femoral head and neck junction and the joint cartilage.
Then, a 22-gauge, 100-mm needle is advanced toward the joint capsule, targeting the junction of the femoral neck and femoral head.
Once the target area is reached, 2 ml of dexamethasone and 2 ml of 0.025% bupivacaine are injected into the joint.
|
Under US guidance, following visualization of the femoral head and neck junction and the articular cartilage, a 22-gauge, 100-mm needle is advanced toward the joint capsule, targeting the junction of the femoral neck and femoral head.
Once the target area is reached, 2 ml of dexamethasone and 2 ml of 0.025% bupivacaine are injected into the joint.
|
|
Intra-articular injection + PENG block
After intra-articularf injection; additionally, during the PENG block, the patient is placed supine, and following sterile cleaning and draping, the anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE) are visualized using a convex ultrasound probe.
The target for the PENG block is the musculo-fascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.
After applying local anesthesia to the skin with 1% lidocaine, a 22-gauge, 100 mm needle is inserted and 2 ml of dexamethasone and 2 ml of 0.025% bupivacaine are injected into the target area.
Patients are monitored for possible complications.
|
In addition to intra-articular injection, the anterior inferior iliac spine and iliopubic eminence are visualized under ultrasound guidance.
A 22-gauge, 100 mm needle is inserted into the musculo-fascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly, and 2 ml of dexamethasone and 2 ml of 0.025% bupivacaine are injected into the target area.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical rating scale (NRS)
Time Frame: Change from baseline to 1st, 3rd and 12th weeks after treatment
|
NRS is a scale that can be used measuring pain.
Scores range from 0 (no pain) to 10 (the worst pain)
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Change from baseline to 1st, 3rd and 12th weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Western Ontario McMaster University Osteoarthritis (WOMAC) Index
Time Frame: Change from baseline to 1st, 3rd and 12th weeks after treatment
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The Western Ontario McMaster University Osteoarthritis (WOMAC) Index consists of a total of 24 questions under 3 main headings: 5 questions related to joint pain, 2 questions on joint stiffness, and 17 questions on physical function in daily life.
(0 = best score, 96 = worst score).
High WOMAC scores indicate increased pain and stiffness, as well as impaired physical function.
|
Change from baseline to 1st, 3rd and 12th weeks after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alp Eren Çelenlioğlu, MD, Gulhane School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hip OA pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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