Intrathecal Morphine in Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695045
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: June 9, 2008
• Start date: July 2003
• Est. completion date: April 2007

Study information

• Verified date: June 2008
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients for elective total knee arthroplasty

Exclusion Criteria:

• No contraindication to spinal

• No allergy to morphine, rescue analgesia or anti-emesis treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Pain, Postoperative

Intervention

Drug:
• intra thecal morphine
100 mcg intrathecal morphine given once .
• intra thecal morphine
200 mcg intrathecal morphine given once
• intra thecal morphine
300 mcg intrathecal morphine given once

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain		24 hours	No
Secondary	nausea and vomiting		24 hours	No
Secondary	pruritus		24 hours	No
Secondary	sedation		24 hours	Yes