NCT00695045

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

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

July 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

Enrollment Period

3.5 years

First QC Date

June 9, 2008

Last Update Submit

June 9, 2008

Conditions

Pain, PostoperativeArthroplasty, Replacement, Knee

Keywords

Pain, PostoperativeArthroplasty, Replacement, KneeMorphineInjections, Intrathecal

Outcome Measures

Primary Outcomes (1)

  • pain

    24 hours

Secondary Outcomes (3)

  • nausea and vomiting

    24 hours

  • pruritus

    24 hours

  • sedation

    24 hours

Study Arms (3)

1

EXPERIMENTAL

patients in this group got 100mcg of intrathecal morphine.

Drug: intra thecal morphine

2

EXPERIMENTAL

patients in this group got 200 mcg intrathecal morphine

Drug: intra thecal morphine

3

EXPERIMENTAL

patients in this group given 300 mcg intrathecal morphine.

Drug: intra thecal morphine

Interventions

intra thecal morphineDRUG

100 mcg intrathecal morphine given once .

Also known as: intraspinal morphine
1

Eligibility Criteria

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

You may qualify if:

  • Patients for elective total knee arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.

    PMID: 18816386DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Patrick D Hassett, MD

    Department of Anaesthesia, UCHG

    PRINCIPAL INVESTIGATOR

  • John Laffey, MD

    Department of Anaesthesia,UCHG

    STUDY CHAIR

  • Brian Kinirons, MD

    Dept of Anaesthesia , UCHG

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

July 1, 2003

Primary Completion

January 1, 2007

Study Completion

April 1, 2007

Last Updated

June 11, 2008

Record last verified: 2008-06