NCT01830296

Brief Summary

Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized study tested the effects of coadministration of patient controlled remifentanil+morphine combination on postthoracotomy pain, analgesic consumption and side effects compared with morphine PCA alone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started May 2011

Typical duration for phase_4 pain

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

May 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

March 27, 2013

Last Update Submit

April 10, 2013

Conditions

Pain

Keywords

Postthoracotomy pain,patient controlled analgesia,remifentanil andmorphine.

Outcome Measures

Primary Outcomes (1)

  • COADMINISTRATION OF INTRAVENOUS REMIFENTANIL AND MORPHINE FOR POSTTHORACOTOMY PAIN; COMPARISON WITH IV MORPHINE ALONE

    As aim of this study was to evaluate the effects of remifentanil addition to morphine for i.v. PCA on analgesic consumption, the primary endpoint was defined as morphine consumption at 24 hour.

    Two years

Study Arms (2)

Remifentanil+Morphine

ACTIVE COMPARATOR

Morphine(M) Remifentanil+Morphine(MR)

Drug: Remifentanil+morphine

IV morphine PCA

ACTIVE COMPARATOR

IV remifentanil+morphine PCA

Drug: Remifentanil+morphine

Interventions

Remifentanil+morphineDRUG

Morphine, Remifentanil+Morphine

Also known as: Morphine Group (M), Remifentanil+Morphine Group (MR)
IV morphine PCARemifentanil+Morphine

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I-III patients, between the ages of 18 and 59 years, scheduled for elective thoracotomy surgery with general anaesthesia were included in this study

You may not qualify if:

  • severe hepatorenal disease history, sensitivity or contraindication to morphine and remifentanil, chronic pain (defined as regular use of opioid analgesics for \> 3 months), drug or alcohol abuse and contraindication to administration of PCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakkı Unlugenc

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mediha Turktan, Assist Prof

    Cukurova University, Department of Anaesthesiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr.

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 12, 2013

Study Start

May 1, 2011

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

TU(1)