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

NCT01242644 | Completed Phase 2 Results

• 1 other identifier: 06-230
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of Narcotic Pills and Morphine Sulfate Used

  In recovery room

• Number of Narcotic Pills and Morphine Sulfate Used

  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

Study Arms (3)

pain pump , injectable medication

EXPERIMENTAL

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

saline pain pump , injectable medication

ACTIVE COMPARATOR

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

injectable medication only

ACTIVE COMPARATOR

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

Drug: ropivacaine, ketorolac , morphine sulfate

Interventions

pain pump containing ropivacaine DEVICE

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

Also known as: ropivacaine, pain, pump

pain pump , injectable medication

saline pain pump with injectable medication DEVICE

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

Also known as: ketorolac, saline

saline pain pump , injectable medication

ropivacaine, ketorolac , morphine sulfate DRUG

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

Also known as: morphine, sulfate

injectable medication only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• knee arthroscopy + synovectomy
• knee arthroscopy + partial or complete meniscectomy
• knee arthroscopy + chondroplasty
• knee arthroscopy + microfracture
• knee arthroscopy + autologous osteoarticular transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Alabama: lead

MeSH Terms

Conditions

Pain

Interventions

Pain Measurement; Ropivacaine; Ketorolac; Morphine; Sulfates

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anions; Ions; Electrolytes; Inorganic Chemicals; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Office of Research Compliance
• Organization: University of South Alabama

swhite@southalabama.edu

251-460-7573

Study Officials

• Albert W Pearsall, MD

  University of South Alabama

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 17, 2010
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2010
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11