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Completed

NCT Number: NCT01169389

Analgesic Control Following Knee Arthroscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Surgery Clinic

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraarticular injection

Procedure

Durolane, one vial

Intra-articular injection of 0.5% Bupivacaine

Procedure

Primary outcomes

  1. Visual Analogue Scale pain score

    Time frame: 1 day

  2. Visual Analogue Scale pain score

    Time frame: 1 week

  3. Visual Analogue Scale pain score

    Time frame: 2 weeks

  4. Visual Analogue Scale pain score

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Orthopaedic Research and Innovation Foundation, Ireland

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 26, 2010
Registry last updated
Jul 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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