- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06389279
The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery
April 30, 2024 updated by: Antalya Training and Research Hospital
The Effect of Ultrasound-guided Pericapsular Nerve Block, Fascia Iliaca Compartment Block and Femoral Block on Postoperative Recovery Quality in Hip Surgery
The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Orthopedic procedures have become increasingly common in clinical practice.
With the increasing elderly population, there have been significant developments in recent years in the field of perioperative pain management and anesthesia strategies for patients scheduled for hip surgery.
Patients undergoing hip surgery may experience severe pain both postoperatively and during the positioning of the patient during surgery.
This leads to increased sympathetic activation such as tachycardia and hypertension in patients, especially in the elderly population, and some undesirable complications due to the patients' existing comorbidities.
Therefore, pain management strategies for patients undergoing hip surgery are based on a range of anesthesia techniques, including the use of opioids, neuraxial anesthesia (spinal, epidural, or a combination of them), nerve blocks, especially pericapsular nerve block (PENG), fascia iliaca compartment block (FICB) and femoral block).
Reducing patients' pain and improving the quality of postoperative recovery has become increasingly important.
The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery.
This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period.
The aim of this study was to evaluate the effect of ultrasound-guided PENG block, FICB block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.
Study Type
Observational
Enrollment (Estimated)
80
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: Arzu Karaveli
- Phone Number: + 90 2422494400
- Email: arzukaraveli@hotmail.com
Study Locations
-
-
-
Antalya, Turkey
- Recruiting
- University of Health Sciences, Antalya Training and Researh Hospital
-
Contact:
- Antalya Training and Research 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
Sampling Method
Non-Probability Sample
Study Population
It is planned to include ASA I-III patients between the ages of 1-85 who are planned to undergo hip fracture surgery under elective spinal anesthesia.
Description
Inclusion Criteria:
- elective hip fracture,
- 18-85 years
- American Society of Anaesthesiology (ASA) I-III
Exclusion Criteria:
- patients planned for general anesthesia
- with multiple fractures
- bleeding disorder
- peripheral neuropathy
- mental disorder
- local anesthetic allergy
- contraindications for spinal anesthesia (local infection, etc.)
- declining to give written informed consent
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 |
|---|---|
|
PENG block group
Before the spinal anesthesia, PENG block will be performed under the guidance of ultrasound.
|
Ultrasound-guided PENG block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
|
|
FIC block group
Before the spinal anesthesia, FIC block will be performed under the guidance of ultrasound.
|
Ultrasound-guided FIC block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
|
|
Femoral block group
Before the spinal anesthesia, femoral block will be performed under the guidance of ultrasound.
|
Ultrasound-guided femoral block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
|
|
Control group
No intervention
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recovery quality
Time Frame: 5 minutes
|
The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery.
This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period.
The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points,
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative Numeric Rating Scale (NRS) pain score
Time Frame: postoperative 24 hours
|
The postoperative pain intensity will be assessed with Numeric Rating Scale (NRS) scores (0 represents no pain and 10 represents the worst possible pain) at postoperative 24 hours.
|
postoperative 24 hours
|
|
postoperative opioid consumption
Time Frame: postoperative 24 hours
|
The amount of postoperative opioid consumption will be recorded
|
postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arzu Karaveli, M.D., University of Health Sciences, Antalya Training and Research Hospital
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
- Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.
- Kalashetty MB, Channappagoudar R, Alwandikar V, Naik DL, Hulakund SY, Guddad A. Comparison of Pericapsular Nerve Group Block with Fascia Iliaca Compartment Block in Adult Patients Undergoing Hip Surgeries: A Double-Blinded Randomized Control Study. Anesth Essays Res. 2022 Jul-Sep;16(3):397-401. doi: 10.4103/aer.aer_123_22. Epub 2022 Dec 9.
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 30, 2024
Primary Completion (Estimated)
September 24, 2024
Study Completion (Estimated)
October 24, 2024
Study Registration Dates
First Submitted
April 24, 2024
First Submitted That Met QC Criteria
April 24, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-18/11
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.
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