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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02495805
• Other study ID #: 1508016335
• Status: Withdrawn
• Phase: N/A
• First received: June 30, 2015
• Last updated: December 8, 2016
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Total Knee Arthroplasty

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor effects	Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.	24 hours (postoperatively)	No
Secondary	Pain score	Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.	On average between 6 and 8 hours postoperatively	No
Secondary	Pain score	Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.	24 hours (postoperatively)	No
Secondary	Opioid consumption	Subjects' pain will be assessed by tracking opioid consumption postoperatively.	On average between 6 and 8 hours postoperatively	No
Secondary	Opioid consumption	Subjects' pain will be assessed by tracking opioid consumption postoperatively.	24 hours (postoperatively)	No
Secondary	Motor effects	Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.	On average between 6 and 8 hours postoperatively	No