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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242644
• Other study ID #: 06-230
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Est. completion date: June 2010

Study information

• Verified date: November 2020
• Source: University of South Alabama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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
• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Alabama

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of Narcotic Pills and Morphine Sulfate Used	Pill count	In recovery room
Secondary	Number of Narcotic Pills and Morphine Sulfate Used	Pill Count	Post surgery day 1
Secondary	Number of Narcotic Pills and Morphine Sulfate Used		Post surgery day 2
Secondary	Number of Narcotic Pills and Morphine Sulfate Used		Post surgery day 3