PainPhase 4NCT01079754
0.05 Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy
A Phase 4 study testing Spinal morphine 0.05 mg and Spinal morphine 0.1 mg in people with Pain and Vaginal Hysterectomy, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Vaginal Hysterectomy
- What is being tested?
- Spinal morphine 0.05 mg and Spinal morphine 0.1 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ASA physical status 1-3
- Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
- Be able to operate patient-controlled analgesia (PCA)
Who cannot join
- Allergy to the study drugs
- History of bleeding tendency
- Infection at the back
- Refuse to spinal anesthesia
- History of CAD or CVA
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of medicine, Siriraj Hospital
Bangkok, 10700
Sirilak Suksompong, MD, 662891534806, sisuk@mahidol.ac.th
Sirilak Suksompong, MD
About this study
Official title: The Comparison of 0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty
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.
- Conditions
- Pain, Vaginal Hysterectomy
- Being tested
- Spinal morphine 0.05 mg, Spinal morphine 0.1 mg
- Keywords
- Spinal morphine 0.05 mg, Spinal morphine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal morphine 0.05 mgDrug
Also called opioids
Patient received spinal morphine 0.05 mg
Spinal morphine 0.1 mgDrug
Also called Opioids
Patient received spinal morphine 0.1 mg
| Study group | Role | What they receive |
|---|---|---|
| Spinal morphine 0.05 mg | Experimental | Patient received spinal morphine 0.05 mg Receives: Drug: Spinal morphine 0.05 mg |
| Spinal morphine 0.1 mg | Active comparator | Patient received spinal morphine 0.1 mg Receives: Drug: Spinal morphine 0.1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of morphine that the patient required during the first 24-h postoperative.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079754
- Sponsor's protocol ID
- Si 073/2010
- Status last verified
- Sep 2011
- First submitted
- 2 Mar 2010
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of 0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty
- ClinicalTrials.gov ID
- NCT01079754
- Acronym / sponsor ID
- Si 073/2010
- Conditions
- Pain, Vaginal Hysterectomy
- Keywords
- Spinal morphine 0.05 mg, Spinal morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal morphine 0.05 mg | Experimental | Drug: Spinal morphine 0.05 mgPatient received spinal morphine 0.05 mg |
| Spinal morphine 0.1 mg | Active comparator | Drug: Spinal morphine 0.1 mgPatient received spinal morphine 0.1 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female ASA physical status 1-3
- Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
- Be able to operate patient-controlled analgesia (PCA)
Key exclusion criteria (5 listed)
- Allergy to the study drugs
- History of bleeding tendency
- Infection at the back
- Refuse to spinal anesthesia
- History of CAD or CVA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal morphine 0.05 mgAlso: opioidsPatient received spinal morphine 0.05 mg | Drug | Spinal morphine 0.05 mg |
| Spinal morphine 0.1 mgAlso: OpioidsPatient received spinal morphine 0.1 mg | Drug | Spinal morphine 0.1 mg |
Primary outcome
The total amount of morphine that the patient required during the first 24-h postoperative.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirilak Suksompong, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal morphine 0.05 mg and Spinal morphine 0.1 mg in people with Pain and Vaginal Hysterectomy, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirilak Suksompong, MD (6624113256, sisuk@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total amount of morphine that the patient required during the first 24-h postoperative. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2011.