- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805661
Adductor Canal Block With Posterior Capsular Injection for Total Knee Replacement
March 16, 2015 updated by: Saint Francis Care
Assessment of Early Ambulation and Participation in Rehabilitation Program in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs Continuous Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement.
To compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control.
The 2 methods are 1) Adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Early mobilization in the postoperative period is important to the success of surgery following total knee replacement.
However, severe post-operative pain is an impediment to early implementation of rehabilitaion program.
The use of femoral nerve block combined with tibial nerve block as part of a multimodal analgesic program provides effective pain control but causes weakness of the operative extremity preventing patients from bearing weight, exercising the leg and increasing the risk of falls thereby delaying early participation in rehabilitation.
Adductor canal block is a new technique that has been described to provide pain control after total knee arthroplasty (1).
The advantages of this block is that it could potentially minimize lower extremity weakness because the target nerve (saphenous nerve) blocked in this technique is a purely sensory nerve and does not provide any motor innervation to any muscle groups.
Adductor canal block lends itself easily to providing prolonged analgesia because a perineural catheter can be inserted and the block maintained by a continuous infusion of dilute local anesthetic solution for days.
A disadvantage of this method is that it may not provide adequate analgesia for posterior knee pain in the early postoperative period.
By combining adductor canal block with ultrasound guided posterior and antero-medial knee injection, the posterior knee pain can be controlled effectively.
Posterior and antero-medial knee injection of local anesthetic solution has been used as a method of controlling posterior knee pain after total knee arthroplasty (2).
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06105
- Saint Francis Hospital and Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients having primary, unilateral total knee arthroplasty
- ages 18 - 80
Exclusion Criteria:
- history of neurological disease
- neuropathy
- diabetes
- major systemic illness
- pregnancy
- chronic narcotic use
- allergy to local anesthetic solution or NSAIDS
- inability to give consent or cooperate with the study protocol
- BMI> 40
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Femoral With Tibial Nerve Block
Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa
|
Continuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml.
|
|
EXPERIMENTAL: Canal Block and Capsular Injection
Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.
|
Continuous Adductor canal block with 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively.
This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to ambulate post operatively.
Time Frame: Up to 3 days (72 hours) post surgery.
|
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
|
Up to 3 days (72 hours) post surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores at rest and with knee flexion.
Time Frame: Up to 3 days ( 72 hours) after surgery
|
Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.
|
Up to 3 days ( 72 hours) after surgery
|
|
Pain Medication Consumption
Time Frame: Up to 3 days (72 hours) post surgery
|
Amount of opioid consumption post surgery for 72 hours.
|
Up to 3 days (72 hours) post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Sinha, M.D., Saint Francis Hospital and Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
March 4, 2013
First Submitted That Met QC Criteria
March 4, 2013
First Posted (ESTIMATE)
March 6, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 16, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-10-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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