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Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

NCT ID: NCT01242644

Last Updated: 2020-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-06-30

Brief Summary

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Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.

Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.

Detailed Description

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Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pain pump , injectable medication

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;

Group Type EXPERIMENTAL

pain pump containing ropivacaine

Intervention Type DEVICE

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour

saline pain pump , injectable medication

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour

Group Type ACTIVE_COMPARATOR

saline pain pump with injectable medication

Intervention Type DEVICE

30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour

injectable medication only

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.

Group Type ACTIVE_COMPARATOR

ropivacaine, ketorolac , morphine sulfate

Intervention Type DRUG

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected

Interventions

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pain pump containing ropivacaine

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour

Intervention Type DEVICE

saline pain pump with injectable medication

30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour

Intervention Type DEVICE

ropivacaine, ketorolac , morphine sulfate

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected

Intervention Type DRUG

Other Intervention Names

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ropivacaine pain pump ketorolac saline morphine sulfate

Eligibility Criteria

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Inclusion Criteria

* knee arthroscopy + synovectomy
* knee arthroscopy + partial or complete meniscectomy
* knee arthroscopy + chondroplasty
* knee arthroscopy + microfracture
* knee arthroscopy + autologous osteoarticular transplantation

Exclusion Criteria

* A surgical procedure that required an incision other then an arthroscopic portal
* A surgical procedure within the same joint within ninety days
* A acute or chronic knee infection
* Any diagnosis of complex regional pain syndrome
* A known allergy to one of the study drugs
* A documented history of narcotic use
* A score of less than two standard deviation on the SF-12 mental component
* Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
* Under the age of eighteen years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Alabama

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert W Pearsall, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama

Other Identifiers

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06-230

Identifier Type: -

Identifier Source: org_study_id