Adductor Canal Block With Posterior Capsular Injection for Total Knee Replacement

Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805661
• Other study ID #: 12-10-002
• Status: Completed
• Phase: N/A
• First received: March 4, 2013
• Last updated: March 16, 2015
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Saint Francis Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Procedure:
• Canal Block and Capsular Injection
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.
• Femoral with Tibial Nerve Block
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.

Locations

Country	Name	City	State
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to ambulate post operatively.	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.	No
Secondary	Pain scores at rest and with knee flexion.	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	No
Secondary	Pain Medication Consumption	Amount of opioid consumption post surgery for 72 hours.	Up to 3 days (72 hours) post surgery	No