NCT00927225

Brief Summary

Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

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

September 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

June 23, 2009

Last Update Submit

June 23, 2009

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    1-6 hours postoperative

Study Arms (2)

active

ACTIVE COMPARATOR

subcutaneous wound infiltration with 50 mL ropivacaine 0.2%

Drug: ropivacaine 0.2%, 50 mL

placebo

PLACEBO COMPARATOR

subcutaneous wound infiltration with 50 mL saline

Drug: normal saline

Interventions

ropivacaine 0.2%, 50 mLDRUG
active
normal salineDRUG
placebo

Eligibility Criteria

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

You may qualify if:

  • total bilateral knee arthroplasty

You may not qualify if:

  • immunological diseases
  • treatment with opioids or steroids
  • allergy to any drugs administered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Andersen LO, Husted H, Kristensen BB, Otte KS, Gaarn-Larsen L, Kehlet H. Analgesic efficacy of subcutaneous local anaesthetic wound infiltration in bilateral knee arthroplasty: a randomised, placebo-controlled, double-blind trial. Acta Anaesthesiol Scand. 2010 May;54(5):543-8. doi: 10.1111/j.1399-6576.2009.02196.x. Epub 2010 Jan 6.

    PMID: 20055763DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 24, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

DK(1)