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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: pain pump containing ropivacaine; Device: saline pain pump with injectable medication; Drug: ropivacaine, ketorolac , 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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	72 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Narcotic Pills and Morphine Sulfate Used	Pill count	In recovery room
Number of Narcotic Pills and Morphine Sulfate Used	Pill Count	Post surgery day 1
Number of Narcotic Pills and Morphine Sulfate Used		Post surgery day 2
Number of Narcotic Pills and Morphine Sulfate Used		Post surgery day 3

Collaborators and Investigators

• Sponsor: University of South Alabama
• Investigators: Principal Investigator: Albert W Pearsall, MD, University of South Alabama

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 11, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ketorolac; Ropivacaine; Morphine; Ketorolac Tromethamine
• Other Study ID Numbers: 06-230