- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06813755
Pericapsular Nerve Group (PENG) Block on Pain During Participant Positioning for Spinal Anesthesia in Hip Fracture Surgery
Effect of Ultrasound (USG)-Guided Pericapsular Nerve Group (PENG) Block on Pain During Participant Positioning for Spinal Anesthesia in Hip Fracture Surgery: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Ultrasonography (USG)-guided regional anesthesia techniques are often used as part of multimodal analgesia in the management of perioperative pain in patients with hip fractures. One of the most recently described blocks used in hip fracture surgery, the USG-guided pericapsular nerve group (PENG) block, aims to directly block the articular branch of the femoral nerve, the articular branch of the obturator nerve, and the accessory obturator nerve, which selectively innervates the anterior aspect of the hip capsule. Case reports and a limited number of clinical studies have reported that PENG block is effective in managing acute fracture-related pain, neuraxial anesthesia positioning pain, and postoperative pain in hip fracture patients.
In this study, investigators aimed to investigate the effect of USG-guided PENG block on positional pain before spinal anesthesia in patients undergoing surgery for hip fractures and to compare this effect with intravenous ketamine.
In addition, investigators aimed to investigate the effect of PENG block on pain scores, perioperative opioid consumption, time to first analgesic requirement in the postoperative period, and quality of recovery in the first 24 hours after surgery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul Training and Research Hospital
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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:
hip fracture aged between 35 and 90 years old
Exclusion Criteria:
contraindications for spinal anesthesia and PENG block impaired cognition or dementia multiple fractures any previous analgesic administration during the last 12 hours
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Procedure: PENG Block Pericapsular Nerve Group Block
Active Comparator: PENG Block For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia.
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Drug: Conventional intravenous sedoanalgesia (ketamine) standardised intravenous sedoanalgesia agent
Active Comparator: Control in this group, standardised sedoanalgesia doses (drug: ketamine) will be used for analgesia for positioning pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain scores on the Numeric Rating Scale (NRS)
Time Frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
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Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals.
NRS is a unidimensional measure of pain intensity in adults.
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
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Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Duration of spinal anesthesia performance
Time Frame: Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
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It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
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Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
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Quality of patient's position
Time Frame: Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
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The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
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Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
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Analgesic consumption
Time Frame: 24 hours
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In the postoperative period, patients will be given opioids according to their pain density with a rescue analgesia agent (tramadol).
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24 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
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
- E-10840098-202.3.02-6997
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
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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