NCT00799175

Brief Summary

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
Last Updated

November 27, 2008

Status Verified

November 1, 2008

Enrollment Period

1.2 years

First QC Date

November 26, 2008

Last Update Submit

November 26, 2008

Conditions

Postoperative Pain

Keywords

Postoperative painLocal infiltration analgesiaKnee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    0-48 hours

Secondary Outcomes (1)

  • hospital stay, pain intensity, side effects, knee function and patient satisfaction scores

    0-3 months

Study Arms (2)

1 Group A(Active)

ACTIVE COMPARATOR

Group A (Active) receives a multimodal injection intra- and postoperatively

Drug: ropivacaine, ketorolac and epinephrine

2 Group P (Placebo)

PLACEBO COMPARATOR

Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively

Drug: saline

Interventions

ropivacaine, ketorolac and epinephrineDRUG

In Group A, 400 mg ropivicaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue. After 21 postoperative hours in Group A, 200 mg ropivicaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.

1 Group A(Active)
salineDRUG

In Group P (placebo) no injections were given intraoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.

2 Group P (Placebo)

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for total knee arthroplasty
  • Aged 20-85 yrs
  • ASA physical status I-III and mobility indicating normal postoperative mobilization

You may not qualify if:

  • Known allergy or intolerance to one of the study drugs
  • Serious liver-, heart- or renal decease
  • Rheumatoid arthritis
  • Chronic pain or bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Orebro

Örebro, 701 85, Sweden

Location

University Hospital Orebro

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineKetorolacEpinephrineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Kjell Axelsson, Prof

    University Hospital Orebro, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

April 1, 2007

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

November 27, 2008

Record last verified: 2008-11

Locations

SE(2)