Management of Postoperative Pain After Total Knee Replacement.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.

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Detailed Description

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Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.

Conditions

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Postoperative Pain Knee Replacement Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nerve Block

Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.

Group Type EXPERIMENTAL

Nerve Block

Intervention Type DRUG

Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.

Periarticular Injection

Injection combination prior to skin closure.

Group Type ACTIVE_COMPARATOR

Periarticular Injection

Intervention Type DRUG

Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.

Interventions

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Nerve Block

Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.

Intervention Type DRUG

Periarticular Injection

Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.

Intervention Type DRUG

Other Intervention Names

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Naropin Naropin Adrenalin Toradol

Eligibility Criteria

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Inclusion Criteria

* Unilateral primary total knee replacement.
* Weight 50-125 kg.
* Age 18-79 years.
* Intact neurological exam to the surgical lower extremity.
* Cognitively intact with ability to sign informed consent.

Exclusion Criteria

* Renal insufficiency with creatinine \>1.5 mg/dL.
* Allergy to medication used in the study.
* Using narcotic medication prior to surgery (morphine equivalents \>=20 mg/day for \>7 days.)
* Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No