NCT01080911

Brief Summary

This study aims to compare the effect of spinal morphine between the dose 0.05 mg and 0.1 mg on the amount of morphine during the first 24 hours postoperative.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

2.8 years

First QC Date

March 3, 2010

Last Update Submit

September 5, 2011

Conditions

Pain

Keywords

Spinal morphineVaginal hysterectomy

Outcome Measures

Primary Outcomes (1)

  • the amount of 24 hours morphine

    24 hour

Study Arms (2)

spinal morphine 0.05 mg

EXPERIMENTAL

spinal morphine 0.05 mg plus 0.5% heavy marcaine 3.5 ml

Drug: Morphine

spinal morphine 0.1 mg

ACTIVE COMPARATOR

spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml

Drug: Morphine

Interventions

MorphineDRUG

spinal morphine 0.05 mg

Also known as: opioid
spinal morphine 0.05 mg

Eligibility Criteria

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

You may qualify if:

  • Female ASA 1-3
  • Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
  • Can operate PCA device

You may not qualify if:

  • History of allergy to the study drugs
  • History of bleeding tendency
  • History of infection at the back
  • Patient refuse to have spinal anesthesia
  • History of CAD or CVD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

MorphineAnalgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Sirilak Suksompong, MD

    Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirilak Suksompong, MD

CONTACT

6624113256sisuk@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

TH(1)