Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
- Conditions
- Pain
- Interventions
- Device: saline pain pump with injectable medicationDrug: ropivacaine, ketorolac , morphine sulfateDevice: 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
All subjects who underwent:
- knee arthroscopy + synovectomy
- knee arthroscopy + partial or complete meniscectomy
- knee arthroscopy + chondroplasty
- knee arthroscopy + microfracture
- knee arthroscopy + autologous osteoarticular transplantation
- 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
Group Intervention Description saline pain pump , injectable medication 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 injectable medication only ropivacaine, ketorolac , morphine sulfate 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. pain pump , injectable medication 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;
- Primary Outcome Measures
Name Time Method Pain Score 8 Hours Post-operativley 8 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 Scale 72 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
Name Time Method Number of Narcotic Pills and Morphine Sulfate Used Post surgery day 3