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Analgesic Control Following Knee Arthroscopy

Analgesic Control Following Knee Arthroscopy: Results of a Randomised , Double-blinded Trial Comparing a Hyaluronic Acid Supplement to Bupivacaine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01169389
Enrollment
98
Registered
2010-07-26
Start date
2009-01-31
Completion date
2009-06-30
Last updated
2010-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee, Arthroscopy, Analgesia

Brief 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.

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.

Interventions

Durolane, one vial

PROCEDUREIntra-articular injection of 0.5% Bupivacaine

Sponsors

Orthopaedic Research and Innovation Foundation, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy * age over 18 years

Exclusion criteria

* 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; * 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.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale pain score1 day

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026