PainPhase 2NCT01242644
Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
A Phase 2 study testing pain pump containing ropivacaine, saline pain pump with injectable medication and ropivacaine, ketorolac , morphine sulfate in people with Pain, run by University of South Alabama.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- pain pump containing ropivacaine, saline pain pump with injectable medication and ropivacaine, ketorolac , morphine sulfate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee arthroscopy + synovectomy
- knee arthroscopy + partial or complete meniscectomy
- knee arthroscopy + chondroplasty
- knee arthroscopy + microfracture
- knee arthroscopy + autologous osteoarticular transplantation
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- pain pump containing ropivacaine, saline pain pump with injectable medication, ropivacaine, ketorolac , morphine sulfate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain pump containing ropivacaineDevice
Also called ropivacaine, pain, pump
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
Also called ketorolac, saline
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
Also called morphine, sulfate
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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 Receives: 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. Receives: Drug: ropivacaine, ketorolac , morphine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 72 hours post surgery
Secondary outcomes (4)
Number of Narcotic Pills and Morphine Sulfate Used
Pill count
Measured: In recovery room
Number of Narcotic Pills and Morphine Sulfate Used
Pill Count
Measured: Post surgery day 1
Number of Narcotic Pills and Morphine Sulfate Used
Measured: Post surgery day 2
Number of Narcotic Pills and Morphine Sulfate Used
Measured: Post surgery day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert W Pearsall, MD, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242644
- Sponsor's protocol ID
- 06-230
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2010
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01242644
- Acronym / sponsor ID
- 06-230
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pain pump , injectable medication | Experimental | Device: pain pump containing ropivacaine30mL 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 , injectable medication | Active comparator | Device: saline pain pump with injectable medication30mL 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 |
| injectable medication only | Active comparator | Drug: ropivacaine, ketorolac , morphine sulfate30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- knee arthroscopy + synovectomy
- knee arthroscopy + partial or complete meniscectomy
- knee arthroscopy + chondroplasty
- knee arthroscopy + microfracture
- knee arthroscopy + autologous osteoarticular transplantation
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain pump containing ropivacaineAlso: ropivacaine, pain, pump30mL 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 , injectable medication |
| saline pain pump with injectable medicationAlso: ketorolac, saline30mL 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 , injectable medication |
| ropivacaine, ketorolac , morphine sulfateAlso: morphine, sulfate30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected | Drug | injectable medication only |
Primary outcome
Pain Score 8 Hours Post-operativley
Time frame: 8 hours post surgery
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).
Pain Scale
Time frame: 24 hours post surgery
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).
Pain Scale
Time frame: 48 hours post-surgery
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).
Pain Scale
Time frame: 72 hours post surgery
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).
4 secondary outcomes
Number of Narcotic Pills and Morphine Sulfate Used
Time frame: In recovery room
Number of Narcotic Pills and Morphine Sulfate Used
Time frame: Post surgery day 1
Number of Narcotic Pills and Morphine Sulfate Used
Time frame: Post surgery day 2
Number of Narcotic Pills and Morphine Sulfate Used
Time frame: Post surgery day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert W Pearsall, MD principal investigator
University of South Alabama
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pain pump containing ropivacaine, saline pain pump with injectable medication and ropivacaine, ketorolac , morphine sulfate in people with Pain, run by University of South Alabama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score 8 Hours Post-operativley (time frame: 8 hours post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.