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Analgesic Control Following Knee Arthroscopy

O

Orthopaedic Research and Innovation Foundation, Ireland

Status

Completed

Conditions

Arthroscopy
Knee
Analgesia

Treatments

Procedure: Intraarticular injection
Procedure: Intra-articular injection of 0.5% Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01169389
KM/10/2008/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

98 participants in 2 patient groups, including a placebo group

Durolane
Active Comparator group
Treatment:
Procedure: Intraarticular injection
Bupivacaine
Placebo Comparator group
Treatment:
Procedure: Intra-articular injection of 0.5% Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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