Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly
Primary Purpose
Hip Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
continuous fascia iliaca compartment block
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria: age > 65 years American Society of Anesthesiologists (ASA) physical status classification class II,III Exclusion Criteria: age < 65 years ASA IIII refusal of peripheral nerve block infection at the site of injection coagulopathy INR > 1.8 platelets count < 50,000 known allergy to used medications.
Sites / Locations
- Ain Shams University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control group
study group
Arm Description
receiving post operative continuous fascia iliaca compartement block for 24 hours
Outcomes
Primary Outcome Measures
Evaluating the postoperative analgesic effect
measuring the degree of postoperative analgesia provided by continuous fascia iliaca compartement block using the Visual analogue score for pain ( 11 point scale where 0 indicates no pain, 10 indicates the worst pain imaginable )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05941208
Brief Title
Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly
Official Title
Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly : a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
The goal of this clinical trial is to investigate the analgesic effect of ultrasound-guided Continuous fascia iliaca block in very elderly patients with hip fracture after hip surgery compared to systemic analgesia .
The main question[s] it aims to answer are:
does continuous fascia iliaca block provide adequate post operative analgesia after hip surgery ?
does it lower the incidence of post operative complications in old age ? Participants will receive continuous fascia iliaca block through ultrasound , introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours.
Researchers will compare the study group receiving continuous fascia iliaca block to the control group receiving traditional systemic analgesia in the post operative period . to see if the analgesic effect is more effective
Detailed Description
Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.
At the end of surgery, Goup 1 will receive continuous fascia iliaca block through ultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head.Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours The control group will receive traditional analgesia including 50 mg pethidine with a maximum 6 hour interval and 1gm paracetamol as per need .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Title
study group
Arm Type
Active Comparator
Arm Description
receiving post operative continuous fascia iliaca compartement block for 24 hours
Intervention Type
Procedure
Intervention Name(s)
continuous fascia iliaca compartment block
Intervention Description
ultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head. Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours,
Primary Outcome Measure Information:
Title
Evaluating the postoperative analgesic effect
Description
measuring the degree of postoperative analgesia provided by continuous fascia iliaca compartement block using the Visual analogue score for pain ( 11 point scale where 0 indicates no pain, 10 indicates the worst pain imaginable )
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 65 years
American Society of Anesthesiologists (ASA) physical status classification class II,III
Exclusion Criteria:
age < 65 years
ASA IIII
refusal of peripheral nerve block
infection at the site of injection
coagulopathy INR > 1.8
platelets count < 50,000
known allergy to used medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydia E Zakhary, MD
Phone
00201222555128
Email
lydia_zakhary@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
samuel H Daniel, MD
Phone
00201224394897
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia E Zakhary, MD
Organizational Affiliation
Ainshams U
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lydia E zakhary, MD
Phone
01222555128
Email
lydia_zakhary@med.asu.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
32361955
Citation
Rasappan K, Chua ITH, Tey JBL, Ho SWL. The continuous infusion fascia iliaca compartment block: a safe and effective analgesic modality in geriatric hip fracture patients. Arch Orthop Trauma Surg. 2021 Jan;141(1):29-37. doi: 10.1007/s00402-020-03450-2. Epub 2020 May 2.
Results Reference
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Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly
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