NCT01037335

Brief Summary

The goal of the current study was to evaluate the analgesic efficacy of low-dose morphine administered to the site of bone graft harvesting in patients undergoing orthopedic surgery. In addition to short-term analgesic effects, the incidence of chronic donor site pain was evaluated 1,3,6 m after surgery.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Status
withdrawn

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

April 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

7.9 years

First QC Date

December 22, 2009

Last Update Submit

April 11, 2017

Conditions

Autogenous Bone Grafts

Keywords

bone graftpainchronic

Outcome Measures

Primary Outcomes (1)

  • pain after procedure

    first 24 hrs

Secondary Outcomes (1)

  • chronic pain formation

    1,3 and 6m

Study Arms (3)

control group

PLACEBO COMPARATOR

10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly.

Drug: morphine

intramuscular morphine

ACTIVE COMPARATOR

10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly

Drug: morphine

donor site morphine

ACTIVE COMPARATOR

5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly.

Drug: morphine

Interventions

morphineDRUG

Group 1 (control group) was given 10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly. Group 2 (intramuscular morphine) was given 10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly. Group 3 (donor site morphine) was given 5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly.

control groupdonor site morphineintramuscular morphine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients on opioids
  • Neuropathic disease
  • Chronic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainBronchiolitis Obliterans Syndrome

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • alparslan turan, md

    cleveland Clinic, outcomes research

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04