- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05444803
Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia
March 9, 2023 updated by: Antalya Training and Research Hospital
Comparison of Femoral Nerve Block Versus Peri-capsular Nerve Group Block for Analgesia During Positioning for Spinal Anesthesia in Patients With Hip Fracture
The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Spinal anesthesia is commonly used in patients undergoing hip fracture surgery.
However the procedure of patient positioning to perform a spinal block is painful and may require the administration of IV analgesics or some regional anesthesia techniques such as femoral nerve block, fascia-iliaca compartment block, peri-capsular nerve group block.
At the study, the investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antalya, Turkey
- 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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with hip fracture scheduled for surgery under spinal anesthesia.
Exclusion Criteria:
- hemorrhagic diathesis,
- peripheral neuropathy,
- allergy to local anesthetics,
- mental disorders,
- use of analgesics for 8 h before the performance of spinal block
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
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Femoral nerve block group
Thirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine.
|
Patients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block.
|
|
Other: Peri-capsular nerve group block group
Thirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine.
|
Patients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia
Time Frame: 30 minutes
|
Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of pain scores at rest
Time Frame: 30 min
|
Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain) at rest before and 30 min after the block performance.
|
30 min
|
|
Rate of pain scores on passive limb lifting
Time Frame: 30 min
|
Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain) on passive limb lifting before and 30 min after the block performance.
|
30 min
|
|
rate of postoperative pain scores
Time Frame: 24 hours
|
Pain scores will be assessed by Numerical Rating Scale (NRS) scores from 0 (no pain) to 10 (maximum possible pain).at
6, 12, 24 hours postoperatively.
|
24 hours
|
|
Amount of postoperative analgesic consumption
Time Frame: 24 hours
|
Postoperative analgesic consumption will be recorded for postoperative 24 hours
|
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)
July 6, 2022
Primary Completion (Actual)
November 7, 2022
Study Completion (Actual)
December 19, 2022
Study Registration Dates
First Submitted
June 20, 2022
First Submitted That Met QC Criteria
July 1, 2022
First Posted (Actual)
July 6, 2022
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- safa1
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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