NCT00219921

Brief Summary

There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 30, 2007

Status Verified

March 1, 2007

First QC Date

September 13, 2005

Last Update Submit

March 29, 2007

Conditions

Total Hip Replacement

Keywords

total hip replacementpain treatment

Outcome Measures

Primary Outcomes (3)

  • VAS-score for pain at movement and at rest every three hours

  • PCA-bolus-sum every three-hour period

  • Morphine-IM rescue dose every three-hour period

Secondary Outcomes (7)

  • patient satisfaction each 24 hours

  • iv-morphine dose needed to attain VAS-score under 40 mm

  • PONV every three hours

  • urine retention every three hours

  • itching every three hours

  • +2 more secondary outcomes

Interventions

Intrathecal morphine at surgery, 0.1mg and placeboDRUG
Patient Controlled Analgesia with iv morphine and placeboDRUG
intrathecal morphine AND patient controlled analgesia with iv morphineDRUG

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower

You may not qualify if:

  • Not able to speak dutch
  • communication problems
  • dementia
  • mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Patient-ControlledMorphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Sibrand Houtman, MD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Study Completion

February 1, 2007

Last Updated

March 30, 2007

Record last verified: 2007-03