- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06169462
Comparison of Pericapsular Nerve Group Block With Suprainguinal Fascia Compartment Block in Hip Fractures
December 13, 2023 updated by: Karaman Training and Research Hospital
Comparison of Pericapsular Nerve Group (PENG) Block Alone Versus Combined With Suprainguinal Fascia Compartment Block (SIFCB) for Postoperative Analgesia and Quality of Recovery in Older Adult Patients With Hip Fractures
Ultrasound-guided Supra-inguinal Fascia Iliaca compartment Block (SIFCB) and Pericapsular Nerve Group Block (PENG) are increasingly being used for postoperative analgesia for hip surgery.
The postoperative analgesic efficacy of SIFCB added to PENG block in elderly hip fracture patients will be evaluated.
Postoperative opioid consumption and quality of recovery will also be evaluated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was conducted as a retrospective cohort feasibility design within a tertiary hospital.
Patient records and electronic data systems were used to gather the required data for analysis.
Before surgery, a carefully selected cohort of patients who underwent PENG block and PENG block added SIFCB were included in the study.
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tayfun Et
- Phone Number: +905063670717
- Email: drtayfunet@gmail.com
Study Locations
-
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Karaman/Merkez
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Karaman, Karaman/Merkez, Turkey, 70200
- Karaman Training and Research Hospital
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-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Data of patients underwent hip surgery under spinal anesthesia between 31.01.2023 and 01.10.2023.
Description
Inclusion Criteria:
- Physical status according to American Society of Anesthesiologists (ASA ) I-III
Exclusion Criteria:
- Previous operation on the same hip
- Hepatic or renal insufficiency
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI >40
- ASA IV
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pericapsular nerve group (PENG) block
Patients who underwent PENG in Hip surgery under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores.
|
Patients underwent ultrasound-guided PENG Block for older adult patients surgery for hip fracture.
Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.
Other Names:
|
Suprainguinal fascia compartment block (SIFCB) + PENG
Patients who underwent PENG+SIFCB in Hip surgery under spinal anesthesia will be evaluated retrospectively in terms of opioid consumption and NRS scores.
|
Patients underwent ultrasound-guided PENG Block+ SIFCB for older adult patients surgery for hip fracture.
Patients who received opioids as a rescue analgesic during postoperative pain management on selected dates will be included in the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid consumption
Time Frame: Postoperative 48th hour
|
If the patient's Numerical Rating Scale (NRS) score is equal to or above 4, tramadol 50 mg IV or oxycodone 5 mg orally every 4 hours will be administered as rescue analgesia.
|
Postoperative 48th hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS) scores
Time Frame: Postoperative 48th hour
|
Range 0-10, 0=no pain, 10=the worse pain ever
|
Postoperative 48th hour
|
Quality of Recovery 15 Score
Time Frame: Postoperative day 1 and 1 month
|
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better
|
Postoperative day 1 and 1 month
|
Postoperative complications
Time Frame: 24 hours
|
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
|
24 hours
|
Mobilization time
Time Frame: 24 hours
|
Mobilization time
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 31, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
December 10, 2023
Study Registration Dates
First Submitted
November 21, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 13, 2023
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-2023/17
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.
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