NCT01242644 - Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

48

Conditions

Pain

Interventions

pain pump containing ropivacaineDEVICE

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

saline pain pump with injectable medicationDEVICE

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

ropivacaine, ketorolac , morphine sulfateDRUG

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Score 8 Hours Post-operativley

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).

Time frame: 8 hours post surgery

Pain Scale

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).

Time frame: 24 hours post surgery

Pain Scale

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).

Time frame: 48 hours post-surgery

Pain Scale

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).

Time frame: 72 hours post surgery

Secondary Outcomes

Number of Narcotic Pills and Morphine Sulfate Used

Pill count

Time frame: In recovery room