Back to resultsPeri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients
Primary Purpose
Spinal Anesthesia, Hip Fractures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
suprainguinal fascia iliaca block
pericapsular nerve group block
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Anesthesia
Eligibility Criteria
Inclusion Criteria: 40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (SA) Exclusion Criteria: any contraindications to SA or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. Patients who had no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support were also excluded.
Sites / Locations
- Haney Baumey
- Facualty of Pharmacy, Al Azhar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FICB group
PENG group
Arm Description
received ultrasound guided suprainguinal fascia iliaca block
received ultrasound guided pericapsular nerve group block
Outcomes
Primary Outcome Measures
NRS
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Secondary Outcome Measures
amount of tramadol used
number of rescue doses of tramadol will be recorded
Full Information
NCT ID
NCT05987254
First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
Al-Azhar University
Collaborators
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT05987254
Brief Title
Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients
Official Title
Comparison Between Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients: A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
Collaborators
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca compartment block (FICB) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block has been proposed to provide effective analgesia in hip fracture patients. However, comparative studies between PENG and FICB are lacking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia, Hip Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FICB group
Arm Type
Active Comparator
Arm Description
received ultrasound guided suprainguinal fascia iliaca block
Arm Title
PENG group
Arm Type
Active Comparator
Arm Description
received ultrasound guided pericapsular nerve group block
Intervention Type
Procedure
Intervention Name(s)
suprainguinal fascia iliaca block
Intervention Description
ultrasound guided suprainguinal fascia iliaca block
Intervention Type
Procedure
Intervention Name(s)
pericapsular nerve group block
Intervention Description
ultrasound guided pericapsular nerve group block
Primary Outcome Measure Information:
Title
NRS
Description
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time Frame
30 minute postoperative
Secondary Outcome Measure Information:
Title
amount of tramadol used
Description
number of rescue doses of tramadol will be recorded
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (SA)
Exclusion Criteria:
any contraindications to SA or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. Patients who had no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support were also excluded.
Facility Information:
Facility Name
Haney Baumey
City
Banhā
ZIP/Postal Code
13518
Country
Egypt
Facility Name
Facualty of Pharmacy, Al Azhar University
City
Cairo
ZIP/Postal Code
11765
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be shared upon resealable request from the principal investigator
Learn more about this trial
Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients
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