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Adductor Canal Block and Recovery After Total Knee Replacement Surgery

NCT ID: NCT02411149

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Total Knee Arthroplasty

Keywords

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Adductor Canal Block Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Local Inflitration Only

This group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia:

* 30 ml normal saline
* 3ml 0.5% preservative-free bupivacaine

Group Type PLACEBO_COMPARATOR

Local Infiltration

Intervention Type DRUG

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.

Adductor Canal Block

This group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic:

* ropivacaine 0.5% with 1:400,000 epinephrine
* 3ml 0.5% preservative-free bupivacaine

Group Type ACTIVE_COMPARATOR

Adductor Canal Block

Intervention Type DRUG

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

This group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic:

* ropivacaine 0.5% with 1:400,000 epinephrine
* 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)

Group Type ACTIVE_COMPARATOR

Adductor Canal Block with Morphine

Intervention Type DRUG

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)

Interventions

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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.

Intervention Type DRUG

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)

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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ropivacaine with epinephrine ropivacaine with epinephrine and spinal intrathecal morphine saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anahi Perlas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto. University Health Network. Toronto Western Hospital.

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20299989 (View on PubMed)

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. doi: 10.1097/00000542-199907000-00006.

Reference Type BACKGROUND
PMID: 10422923 (View on PubMed)

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. doi: 10.2106/JBJS.E.00344.

Reference Type BACKGROUND
PMID: 16651569 (View on PubMed)

Biswas A, Perlas A, Ghosh M, Chin K, Niazi A, Pandher B, Chan V. Relative Contributions of Adductor Canal Block and Intrathecal Morphine to Analgesia and Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):154-160. doi: 10.1097/AAP.0000000000000724.

Reference Type DERIVED
PMID: 29315129 (View on PubMed)

Other Identifiers

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13-7016-A

Identifier Type: -

Identifier Source: org_study_id