Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty

Sponsor

Yale University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02495805

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty	Procedure: Continuous proximal adductor canal block Procedure: Continuous femoral nerve block	N/A

Detailed Description

Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: adductor canal block (ACB) Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.	Procedure: Continuous proximal adductor canal block Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB). Other Names: ACB
Active Comparator: femoral nerve block (FNB) Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.	Procedure: Continuous femoral nerve block Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB). Other Names: FNB

Arm

Intervention/Treatment

Active Comparator: adductor canal block (ACB)

Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.

Procedure: Continuous proximal adductor canal block

Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Other Names:

ACB

Active Comparator: femoral nerve block (FNB)

Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.

Procedure: Continuous femoral nerve block

Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Other Names:

FNB

Outcome Measures

Primary Outcome Measures

Motor effects [24 hours (postoperatively)]
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.

Secondary Outcome Measures

Pain score [On average between 6 and 8 hours postoperatively]
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Pain score [24 hours (postoperatively)]
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Opioid consumption [On average between 6 and 8 hours postoperatively]
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Opioid consumption [24 hours (postoperatively)]
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Motor effects [On average between 6 and 8 hours postoperatively]
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
The patient will need to be able to have decision-making capacity and ability to consent for the study.

Exclusion Criteria:

Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
Patients unable to have decision-making capacity and ability to consent for the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Richa Wardham, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT02495805

Other Study ID Numbers:

1508016335

First Posted:

Jul 13, 2015

Last Update Posted:

Dec 9, 2016

Last Verified:

Dec 1, 2016

Keywords provided by Yale University

a continuous proximal adductor canal block (ACB)

continuous femoral nerve block (FNB)

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Dec 9, 2016