KneeNCT01169389
Analgesic Control Following Knee Arthroscopy
A study testing Intraarticular injection and Intra-articular injection of 0.5% Bupivacaine in people with Knee and Arthroscopy, run by Orthopaedic Research and Innovation Foundation, Ireland at 1 site in Ireland.
Trial summary
This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee, Arthroscopy, Analgesia
- What is being tested?
- Intraarticular injection and Intra-articular injection of 0.5% Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy
- age over 18 years
Who cannot join
- American Society of Anaesthesiologists (ASA) grade ≥3;
- arthroscopic assisted osteotomies;
- a history of two or more prior procedures on the ipsilateral knee;
- post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE);
- systemic steroid requirements;
- previous intra-articular anaesthetic or steroid injection within the last three months;
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- intra-articular HA injection within the last nine months;
- intra-articular sepsis within the previous three months;
- prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Control Following Knee Arthroscopy: Results of a Randomised , Double-blinded Trial Comparing a Hyaluronic Acid Supplement to Bupivacaine
This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.
Read the detailed description
There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.
- Conditions
- Knee, Arthroscopy, Analgesia
- Being tested
- Intraarticular injection, Intra-articular injection of 0.5% Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarticular injectionProcedure or surgery
Durolane, one vial
Intra-articular injection of 0.5% BupivacaineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Durolane | Active comparator | Not described Receives: Procedure: Intraarticular injection |
| Bupivacaine | Placebo comparator | Not described Receives: Procedure: Intra-articular injection of 0.5% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale pain score
Measured: 1 day
Visual Analogue Scale pain score
Measured: 1 week
Visual Analogue Scale pain score
Measured: 2 weeks
Visual Analogue Scale pain score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KneeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Research and Innovation Foundation, Ireland
- Sponsor type
- University, hospital or other
- Investigators
- Kevin J Mulhall, FRCSI, Principal investigator, Orthopaedic Research and Innovation Foundation, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169389
- Sponsor's protocol ID
- KM/10/2008/18
- Status last verified
- Dec 2008
- First submitted
- 23 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Control Following Knee Arthroscopy: Results of a Randomised , Double-blinded Trial Comparing a Hyaluronic Acid Supplement to Bupivacaine
- ClinicalTrials.gov ID
- NCT01169389
- Acronym / sponsor ID
- KM/10/2008/18
- Conditions
- Knee, Arthroscopy, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Orthopaedic Research and Innovation Foundation, IrelandUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.
Detailed description
There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durolane | Active comparator | Procedure: Intraarticular injection |
| Bupivacaine | Placebo comparator | Procedure: Intra-articular injection of 0.5% Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy
- age over 18 years
Key exclusion criteria (9 listed)
- American Society of Anaesthesiologists (ASA) grade ≥3;
- arthroscopic assisted osteotomies;
- a history of two or more prior procedures on the ipsilateral knee;
- post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE);
- systemic steroid requirements;
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 |
|---|---|---|
| Intraarticular injectionDurolane, one vial | Procedure or surgery | Durolane |
| Intra-articular injection of 0.5% Bupivacaine | Procedure or surgery | Bupivacaine |
Primary outcome
Visual Analogue Scale pain score
Time frame: 1 day
Visual Analogue Scale pain score
Time frame: 1 week
Visual Analogue Scale pain score
Time frame: 2 weeks
Visual Analogue Scale pain score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
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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.
Kevin J Mulhall, FRCSI principal investigator
Orthopaedic Research and Innovation Foundation, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraarticular injection and Intra-articular injection of 0.5% Bupivacaine in people with Knee and Arthroscopy, run by Orthopaedic Research and Innovation Foundation, Ireland at 1 site in Ireland.
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 2 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 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale pain score (time frame: 1 day). 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 30 Jul 2010.