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

University of South Alabama (USA)

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Device: pain pump containing ropivacaine; Device: saline pain pump with injectable medication; Drug: ropivacaine, ketorolac , morphine sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01242644

06-230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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48 participants in 3 patient groups

pain pump , injectable medication

Experimental group

Description:

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;

Treatment:

Device: pain pump containing ropivacaine

saline pain pump , injectable medication

Active Comparator group

Description:

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

Treatment:

Device: saline pain pump with injectable medication

injectable medication only

Active Comparator group

Description:

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

Treatment:

Drug: ropivacaine, ketorolac , morphine sulfate