NCT01079754

Brief Summary

This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty.

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

Typical duration 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
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

1.8 years

First QC Date

March 2, 2010

Last Update Submit

September 10, 2011

Conditions

PainVaginal Hysterectomy

Keywords

Spinal morphine 0.05 mgSpinal morphine

Outcome Measures

Primary Outcomes (1)

  • The total amount of morphine that the patient required during the first 24-h postoperative.

    24 hours

Study Arms (2)

Spinal morphine 0.05 mg

EXPERIMENTAL

Patient received spinal morphine 0.05 mg

Drug: Spinal morphine 0.05 mg

Spinal morphine 0.1 mg

ACTIVE COMPARATOR

Patient received spinal morphine 0.1 mg

Drug: Spinal morphine 0.1 mg

Interventions

Spinal morphine 0.05 mgDRUG

Patient received spinal morphine 0.05 mg

Also known as: opioids
Spinal morphine 0.05 mg
Spinal morphine 0.1 mgDRUG

Patient received spinal morphine 0.1 mg

Also known as: Opioids
Spinal morphine 0.1 mg

Eligibility Criteria

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

You may qualify if:

  • Female ASA physical status 1-3
  • Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
  • Be able to operate patient-controlled analgesia (PCA)

You may not qualify if:

  • Allergy to the study drugs
  • History of bleeding tendency
  • Infection at the back
  • Refuse to spinal anesthesia
  • History of CAD or CVA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Sirilak Suksompong, MD

    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 2, 2010

First Posted

March 3, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

TH(1)