NCT01169389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
Last Updated

July 30, 2010

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

July 23, 2010

Last Update Submit

July 29, 2010

Conditions

KneeArthroscopyAnalgesia

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale pain score

    1 day

  • Visual Analogue Scale pain score

    1 week

  • Visual Analogue Scale pain score

    2 weeks

  • Visual Analogue Scale pain score

    6 weeks

Study Arms (2)

Durolane

ACTIVE COMPARATOR
Procedure: Intraarticular injection

Bupivacaine

PLACEBO COMPARATOR
Procedure: Intra-articular injection of 0.5% Bupivacaine

Interventions

Intraarticular injectionPROCEDURE

Durolane, one vial

Durolane
Intra-articular injection of 0.5% BupivacainePROCEDURE
Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Surgery Clinic

Dublin, Ireland

Location

MeSH Terms

Conditions

Agnosia

Interventions

Injections, Intra-ArticularBupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeuticsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kevin J Mulhall, FRCSI

    Orthopaedic Research and Innovation Foundation, Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

July 30, 2010

Record last verified: 2008-12

Locations

IE(1)