Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534697
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty a Randomised Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIB-PAIN
Brief Summary:
This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment The main question it aims to answer is
What is the total morphine mg consumption at 24 hours postoperatively for each of the three groups
The secondary questions are
What is the length of stay in hospital for each group
What is the risk of falling associated with the use of fascia iliaca block Researchers will compare two analgesic combinations of local anesthestic naropin 025 versus dextrose 10 administered by fascia iliaca block for postoperative pain after total hip arthroplasty
What is the total morphine mg consumption at 24 hours postoperatively for each of the three groups
The secondary questions are
What is the length of stay in hospital for each group
What is the risk of falling associated with the use of fascia iliaca block Researchers will compare two analgesic combinations of local anesthestic naropin 025 versus dextrose 10 administered by fascia iliaca block for postoperative pain after total hip arthroplasty
Detailed Description:
The investigators plan to conduct a single-center prospective blinded randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024 All patients will receive spinal anesthesia and preoperatively FIB for analgesia The investigators define randomly three patient groups Group 1 receiving 40 ml naropin 025 in saline Group 2 receiving 40 ml naropin 025 in dextrose 5 and Group 3 receiving 40 ml dextrose 10 After the regression of spinal anesthesia all the patients receive the same multimodal pain therapy according to the visual analog scale VAS including Paracetamol IV NSAID and morphine according to the pain protocol in our hospital The primary endpoint of the study is total morphine mg consumption at 24 hours postoperatively and the secondary goals were length of stay and the risk of fall
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None