Self Medication With Oral Morphine After Total Knee Arthroplasty.

Self Medication With Oral Morphine After Total Knee Arthroplasty. A Randomised Controlled Trial Comparing Self Medication With Standard Nurse Dispensing. Is There a Difference in Morphine Consumption, Pain, Patient Satisfaction or Safety?

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.

Study Overview

• Status: Completed
• Conditions: Pain Control; Arthroplasty, Knee Replacement
• Intervention / Treatment: Behavioral: Nurse dispensed oral morphine.; Behavioral: Patient self medication of oral morphine.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset.
    • Bournemouth., Dorset., United Kingdom, BH7 7DW
      • Derwent Unit, Royal Bournemouth Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nurse dispensed oral morphine solution.	Behavioral: Nurse dispensed oral morphine.; Nurse will dispense oral morphine on request from the patient.
ACTIVE_COMPARATOR: Self medicated oral morphine solution.	Behavioral: Patient self medication of oral morphine.; Patients will self medicate their oral morphine pain control solution following surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Royal Bournemouth Hospital
• Collaborators: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Jonathan Linton, Doctor, Poole Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: October 21, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (ESTIMATE): October 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Knee replacement; Pain control; Self medication
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 10/H0505/77