Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02218814
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-08-01
Brief Title:
Study to Evaluate ACB Versus FNB Early Postoperative Period Functional Outcomes After TKA
Sponsor:
George Macrinici
Organization:
Presence Saint Joseph Medical Center
Study Overview
Official Title:
Prospective Double-blind Randomized Study to Evaluate a Single Shot Adductor Canal Nerve Block Versus Femoral Nerve Block Combined With LIA Local Infiltration Analgesia Early Postoperative Period Functional Outcomes After Total Knee Replacement
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACB
Brief Summary:
The purpose of this study is to determine if patients undergoing a Total Knee Arthroplasty who receive a single shot Adductor Canal nerve block and local infiltration will have improved functional outcomes compared to individuals who receive a femoral nerve block and local infiltration during the first 24 hours post surgery
Detailed Description:
Title Prospective Double-blind Randomized Study to Evaluate a Single Shot Adductor Canal Nerve Block versus Femoral Nerve Block combined with LIA Local Infiltration Analgesia Early Postoperative Period Functional Outcomes after Total Knee Arthroplasty
Objectives
Primary To determine if patients undergoing a Total Knee Arthroplasty who receive an Adductor Canal block will result in increased quadriceps muscle strength MVIC compared to those who receive a Femoral Nerve block at 24 hours
Secondary The secondary objective is to determine whether Adductor Canal nerve block results in improved functional outcomes as evidenced by Time up and GO Range of Motion and Six-Minute Walk Test at 24 hours 48 hours and 6 months
To assess post-operative pain as measured by the Visual Analog pain score VAS immediately prior to the start of during and after each in-patient physical therapy session
Study Design Prospective double-blind randomized study
Description of Intervention The devices to be used in this study are intended for nerve blocks and consist of 13-6 MHz linear ultrasound transducer SonoSite HFL38x Washington US a 22-gauge 50-mm short-bevel stimulating needle Stimuplex B Braun Bethlehem Pennsylvania BBraun Stimuplex DIG RC Bupivacaine HCl 100 mg injected in the Adductor Canal or around the Femoral nerve
Femoral nerve block in combination with local infiltration analgesia is the standard of care in the investigators institution at present
Bupivacaine HCl 100 mg in combination with Toradol 30 mg are used for local infiltration of the anterior lateral and lateral posterior side of the knee done by the surgeon using a standard technique
Subject PopulationThe study will include both male and female adults who will meet the inclusion criteria and none of exclusion criteria For each patient time to conduct the blocks will vary between 5-10 minutes local infiltration analgesia between 5-10 minutes physical therapy tests between 30 minutes and one hour each encounter VAS pain assessment between 2-5 minutes
Subject Participation DurationThe rate of patient accrual and the prescribed follow-up time the total duration of this study is expected to be approximately 18 months where enrollment is expected to occur over 12 months with a follow-up period of 6 months in the physical therapy office visits
Number of PatientsThe study will include 120 patients
Number of Sites The study will include one site
Study DurationThe expected study duration is approximately 18 months
Endpoints Endpoints of this study will include quadriceps muscle strength ROM of the knee TUG 6 minute walk test knee pain score VAS activities of daily living adverse events and will be studied from the baseline up to 6 month after TKR VAS pain score will be assessed at each physical therapy encounter
Objectives
Primary To determine if patients undergoing a Total Knee Arthroplasty who receive an Adductor Canal block will result in increased quadriceps muscle strength MVIC compared to those who receive a Femoral Nerve block at 24 hours
Secondary The secondary objective is to determine whether Adductor Canal nerve block results in improved functional outcomes as evidenced by Time up and GO Range of Motion and Six-Minute Walk Test at 24 hours 48 hours and 6 months
To assess post-operative pain as measured by the Visual Analog pain score VAS immediately prior to the start of during and after each in-patient physical therapy session
Study Design Prospective double-blind randomized study
Description of Intervention The devices to be used in this study are intended for nerve blocks and consist of 13-6 MHz linear ultrasound transducer SonoSite HFL38x Washington US a 22-gauge 50-mm short-bevel stimulating needle Stimuplex B Braun Bethlehem Pennsylvania BBraun Stimuplex DIG RC Bupivacaine HCl 100 mg injected in the Adductor Canal or around the Femoral nerve
Femoral nerve block in combination with local infiltration analgesia is the standard of care in the investigators institution at present
Bupivacaine HCl 100 mg in combination with Toradol 30 mg are used for local infiltration of the anterior lateral and lateral posterior side of the knee done by the surgeon using a standard technique
Subject PopulationThe study will include both male and female adults who will meet the inclusion criteria and none of exclusion criteria For each patient time to conduct the blocks will vary between 5-10 minutes local infiltration analgesia between 5-10 minutes physical therapy tests between 30 minutes and one hour each encounter VAS pain assessment between 2-5 minutes
Subject Participation DurationThe rate of patient accrual and the prescribed follow-up time the total duration of this study is expected to be approximately 18 months where enrollment is expected to occur over 12 months with a follow-up period of 6 months in the physical therapy office visits
Number of PatientsThe study will include 120 patients
Number of Sites The study will include one site
Study DurationThe expected study duration is approximately 18 months
Endpoints Endpoints of this study will include quadriceps muscle strength ROM of the knee TUG 6 minute walk test knee pain score VAS activities of daily living adverse events and will be studied from the baseline up to 6 month after TKR VAS pain score will be assessed at each physical therapy encounter
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