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

Phase 2
Completed
Conditions
Pain
Interventions
Device: saline pain pump with injectable medication
Drug: ropivacaine, ketorolac , morphine sulfate
Device: pain pump containing ropivacaine
Registration Number
NCT01242644
Lead Sponsor
University of South Alabama
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
saline pain pump , injectable medicationsaline pain pump with injectable medication30mL 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 onlyropivacaine, ketorolac , morphine sulfate30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
pain pump , injectable medicationpain pump containing ropivacaine30mL 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;
Primary Outcome Measures
NameTimeMethod
Pain Score 8 Hours Post-operativley8 hours post surgery

Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

Pain Scale72 hours post surgery

Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

Secondary Outcome Measures
NameTimeMethod
Number of Narcotic Pills and Morphine Sulfate UsedPost surgery day 3
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