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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Albert Pearsall, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01242644
First received: November 11, 2010
Last updated: June 26, 2013
Last verified: June 2013
  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 Blind (Subject, 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 University of South Alabama:

Primary Outcome Measures:
  • VAS Pain Score [ Time Frame: Day of surgery until 9 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic Arthritis [ Time Frame: Day of surgery until 9 months post-operatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01242644

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

No publications provided

Responsible Party: Albert Pearsall, Professor, Orthopaedic Surgery, University of South Alabama
ClinicalTrials.gov Identifier: NCT01242644     History of Changes
Other Study ID Numbers: 06-230
Study First Received: November 11, 2010
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Morphine
Ketorolac
Ketorolac Tromethamine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on October 01, 2014