Adductor Canal Block and Recovery After Total Knee Replacement Surgery

Total Knee Arthroplasty Clinical Trial

— ACB in TKA  

Official title:

Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411149
• Other study ID #: 13-7016-A
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2015
• Last updated: November 21, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment

Description:

The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.

Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.

The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists Physical Status I-III

• 18 - 80 years of age

• BMI 18 - 40

• Scheduled for elective total knee replacement under spinal anesthesia

• Able to ambulate independently with a standard wheeled walker as maximum mobility aid

Exclusion Criteria:

• Revision knee arthroplasty

• Bilateral knee arthroplasty

• Lack of mental ability to provide informed consent

• Neuropathic pain or sensory disorders of the surgical limb

• Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)

• Chronic opioid use defined as > 30 mg of daily oral morphine equivalents

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• Adductor Canal Block
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.
• Adductor Canal Block with Morphine
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
• Local Infiltration
30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. — View Citation

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. — View Citation

Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go test	TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.	2-3 days post srugery
Secondary	Pain outcome - NRS	a) Pain scores assessed with an 11 point verbal numeric rating scale (NRS) where 0 is "no pain" and 10 is "the worst pain imaginable", both at rest and during active physiotherapy (measured daily for 3 days post-operatively) .	2-3 days post surgery
Secondary	Analgesic outcomes - Cumulative systemic opioid consumption	Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively).	2-3 days post surgery
Secondary	Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia	Proportion of patients who required "rescue" intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period.	2-3 days post surgery
Secondary	Analgesic outcomes - Incidence of opioid-related side effects	Incidence of opioid-related side effects	2-3 days post surgery
Secondary	Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees	Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively)	2-3 days post surgery
Secondary	Secondary short-term physical and performance-based functional outcome measures - Distance walked	Distance walked	2-3 days post surgery
Secondary	Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay	Hospital length of stay	2-3 days post surgery
Secondary	Secondary short-term physical and performance-based functional outcome measures - Discharge destination	Discharge destination (home or rehabilitation facility)	2-3 days post surgery
Secondary	Medium-term self-reported functional outcome measures - WOMAC	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively	baseline and 2-3 days post surgery
Secondary	Medium-term self-reported functional outcome measures - LEFS	Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively.	baseline and 2-3 days post surgery