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Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia

Primary Purpose

Spinal Anesthesia, Analgesia, Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
femoral nerve block
peri-capsular nerve group block
Sponsored by
Antalya Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Anesthesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Antalya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Femoral nerve block group

Peri-capsular nerve group block group

Arm Description

Thirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine.

Thirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine.

Outcomes

Primary Outcome Measures

Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia
Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).

Secondary Outcome Measures

Rate of pain scores at rest
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.
Rate of pain scores on passive limb lifting
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.
rate of postoperative pain scores
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.
Amount of postoperative analgesic consumption
Postoperative analgesic consumption will be recorded for postoperative 24 hours

Full Information

First Posted
June 20, 2022
Last Updated
March 9, 2023
Sponsor
Antalya Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05444803
Brief Title
Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia
Official Title
Comparison of Femoral Nerve Block Versus Peri-capsular Nerve Group Block for Analgesia During Positioning for Spinal Anesthesia in Patients With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia, Analgesia, Hip Fractures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral nerve block group
Arm Type
Other
Arm Description
Thirty minutes before the placement of spinal block, patients will be receive a femoral nerve block with Bupivacaine.
Arm Title
Peri-capsular nerve group block group
Arm Type
Other
Arm Description
Thirty minutes before the placement of spinal block, patients will be receive a peri-capsular nerve group block with Bupivacaine.
Intervention Type
Other
Intervention Name(s)
femoral nerve block
Intervention Description
Patients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block.
Intervention Type
Other
Intervention Name(s)
peri-capsular nerve group block
Intervention Description
Patients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block.
Primary Outcome Measure Information:
Title
Rate of pain scores assessed by Numerical rating Score Scale during positioning for spinal anesthesia
Description
Pain scores will be assessed by Numerical Rating Scale (NRS) scores (from 0=no pain to 10=maximum possible pain).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Rate of pain scores at rest
Description
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.
Time Frame
30 min
Title
Rate of pain scores on passive limb lifting
Description
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.
Time Frame
30 min
Title
rate of postoperative pain scores
Description
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.
Time Frame
24 hours
Title
Amount of postoperative analgesic consumption
Description
Postoperative analgesic consumption will be recorded for postoperative 24 hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safa Eroglu, M.D.
Organizational Affiliation
Antalya Traning and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital
City
Antalya
Country
Turkey

12. IPD Sharing Statement

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Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia

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