- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885739
Continuous Pericapsular Nerve Group Block in Hip Fracture Patients
Background- Despite clinical guidelines favoring surgical repair of hip fracture (HF) within 48 hours of injury, patients may wait considerable periods of time for their turn in the operating room. In this context, continuous nerve blocks are an attractive alternative for pain management. However, the ideal block technique is not yet defined. Recently a new ultrasound-guided approach for selective blockade of the articular branches to the hip, the PENG (Pericapsular Nerve Group) block, has been proposed with potentials advantages for perioperative hip fracture analgesia.
Objective- To describe the analgesic efficacy and feasibility of continuous Pericapsular Nerve Group block (CPENGB) in patients with HF.
Design-Interventional study. Setting-Academic Level 3 center. Methods- Two experienced anesthesiologist completed 15 sonographically guided Pericapsular Nerve Group (PENG) injections and catheter insertion in patients with severe pain awaiting HF surgery. Each injection consisted of 20 mL of local anesthetics followed by a 0.1% bupivacaine continuous infusion at a constant rate of 8 ml per hour. Pain at rest and on 15° leg lift of the fractured leg were assessed before procedure, 10 and 30 minutes after block performance, and each 24 hours until surgery. A reduction of severe or moderate dynamic pain to mild pain or no pain, and a pain relief of 2 (moderate) were clinically significant findings. To determine feasibility time and number of attempts to perform the procedure were measured.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Antioquia
-
Medellin, Antioquia, Colombia
- Hospital Universitario San Vicente Fundación
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults
- Acute hip fractures
- Severe pain
- Patients, or their legal representatives, provided written informed consent for procedure.
Exclusion Criteria:
- Women in pregnancy
- Trauma score greater than or equal to 16
- Incomplete data
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients with hip fracture
15 consecutive HF patients who were admitted to a single level 3 center and who report severe pain despite a standardized analgesia protocol.
Patients were assessed by the Pain Service as part of a multidisciplinary care pathway and a Continuous Pericapsular Nerve Group blocks was offered as a component of a multimodal analgesic regimen.
|
Continuous Pericapsular Nerve Group block to standardize the approach.
Injections were performed using a curvilinear low-frequency ultrasound probe (3.5- to 5-MHz).
The lateral border of iliopsoas tendon in an oblique axial plane at level of iliopectineal eminence provides target for needle placement.
Toggling the transducer was necessary to optimize visualization of the iliopsoas tendon secondary to anisotropy.
Injections were performed using an 18-gauge Tuohy needle under sterile conditions.
Then, 10 mL 0.25% bupivacaine was administered and a 20-G polyamide catheter (connect to a filter) was advanced into the space.
The end point of the catheter placement was the direct visualization of microbubbles in a peritendinous distribution using a bolus of agitated saline applied through threaded catheter connected to not purged filter.
After catheter placement patients received a 0.1% bupivacaine continuous infusion at a constant rate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Rating Scale with four response categories, VRS-4
Time Frame: Before procedure
|
Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''.
Pain at rest and on movement (pain on 15° leg lift of the fractured leg)
|
Before procedure
|
Verbal Rating Scale with four response categories, VRS-4
Time Frame: 10 minutes after procedure
|
Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''.
Pain at rest and on movement (pain on 15° leg lift of the fractured leg)
|
10 minutes after procedure
|
Verbal Rating Scale with four response categories, VRS-4
Time Frame: 30 minutes after procedure
|
Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''.
Pain at rest and on movement (pain on 15° leg lift of the fractured leg)
|
30 minutes after procedure
|
Verbal Rating Scale with four response categories, VRS-4
Time Frame: 24 hours after procedure
|
Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''.
Pain at rest and on movement (pain on 15° leg lift of the fractured leg)
|
24 hours after procedure
|
Verbal Rating Scale with four response categories, VRS-4
Time Frame: 48 hours after procedure
|
Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''.
Pain at rest and on movement (pain on 15° leg lift of the fractured leg)
|
48 hours after procedure
|
Collaborators and Investigators
Sponsor
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
- UdeA1004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Hip Fractures
-
Smith & Nephew, Inc.Terminated
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
Carilion ClinicCompleted
-
FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
-
Rabin Medical CenterUnknown
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
Clinical Trials on Continuous Pericapsular Nerve Group block
-
Jacobi Medical CenterCompleted
-
Guangzhou First People's HospitalUnknownAnalgesia | Arthroplasty | Nerve BlockChina
-
Henan Provincial People's HospitalNot yet recruitingPain After Shoulder Surgery
-
Ilker ItalAbant Izzet Baysal UniversityRecruitingPostoperative Pain | Hip FracturesTurkey
-
LifeBridge HealthRubin Institute for Advanced OrthopedicsRecruitingHip Osteoarthritis | Hip ArthropathyUnited States
-
Gulhane School of MedicineCompletedDiabetic Foot | Wound Heal | Regional Anesthesia | Catheter BlockageTurkey
-
Huazhong University of Science and TechnologyRecruiting
-
Selcuk UniversityNot yet recruitingPostoperative Pain
-
The University of Hong KongRecruiting
-
Tanta UniversityUnknownPost Operative Pain After Pediatric Hip SurgeryEgypt