NCT01226186

Brief Summary

The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

October 21, 2010

Last Update Submit

December 3, 2012

Conditions

Keywords

Knee replacementPain controlSelf medication

Outcome Measures

Primary Outcomes (1)

  • To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine.

    one year

Secondary Outcomes (2)

  • To identify if patients who self medicate with oral morphine take a significantly different amount of morphine compared with those who take nurse dispensed oral morphine.

    one year

  • To compare whether patients who self medicate with oral morphine have a significantly altered level of side effects compared with those who take nurse dispensed oral morphine.

    one year

Study Arms (2)

Nurse dispensed oral morphine solution.

ACTIVE COMPARATOR
Behavioral: Nurse dispensed oral morphine.

Self medicated oral morphine solution.

ACTIVE COMPARATOR
Behavioral: Patient self medication of oral morphine.

Interventions

Nurse will dispense oral morphine on request from the patient.

Nurse dispensed oral morphine solution.

Patients will self medicate their oral morphine pain control solution following surgery.

Self medicated oral morphine solution.

Eligibility Criteria

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

You may qualify if:

  • Patients requiring total knee replacement surgery willing to provide written, informed consent.

You may not qualify if:

  • Unable to safely self medicate.
  • Allergy to morphine.
  • Unable to provide consent.
  • Contraindication to the standardised anaesthetic or standard postoperative care.
  • Not consenting to an element of the standardised anaesthetic.
  • Pre-operative use of strong opiates e.g. Oramorph, MST, Oxynorm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derwent Unit, Royal Bournemouth Hospital.

Bournemouth, Dorset., BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jonathan Linton, Doctor

    Poole Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 22, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations