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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242644
First Posted: November 17, 2010
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Albert Pearsall, University of South Alabama
  Purpose

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.


Condition Intervention Phase
Pain Device: pain pump containing ropivacaine Device: saline pain pump with injectable medication Drug: ropivacaine, ketorolac , morphine sulfate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

Resource links provided by NLM:


Further study details as provided by Albert Pearsall, University of South Alabama:

Primary Outcome Measures:
  • VAS Pain Score [ Time Frame: Day of surgery until 9 months post-operatively ]

Secondary Outcome Measures:
  • Radiographic Arthritis [ Time Frame: Day of surgery until 9 months post-operatively ]

Enrollment: 49
Study Start Date: October 2006
Study Completion Date: June 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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;
Device: 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
Other Names:
  • ropivacaine
  • pain
  • pump
Active Comparator: 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
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
Other Names:
  • ketorolac
  • saline
Active Comparator: injectable medication only
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
Drug: ropivacaine, ketorolac , morphine sulfate
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Other Names:
  • morphine
  • sulfate

Detailed Description:

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.

There were 24 males and 25 females, with a mean age of 51.2 years. On the first post-operative day, Group B patients had significantly less pain and used significantly less pain pills. There was no significant difference in pain scores between Groups A and C on this day. No significant difference in pain scores was found among the 3 groups for all other time intervals. At nine months, all patients had subjective pain of < 2 and there was no difference in pre-op and recent radiographic scores.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All subjects who underwent:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242644


Sponsors and Collaborators
University of South Alabama
Investigators
Principal Investigator: Albert W Pearsall, MD University of South Alabama
  More Information

Responsible Party: Albert Pearsall, Professor, Orthopaedic Surgery, University of South Alabama
ClinicalTrials.gov Identifier: NCT01242644     History of Changes
Other Study ID Numbers: 06-230
First Submitted: November 11, 2010
First Posted: November 17, 2010
Last Update Posted: June 28, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Morphine
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action