- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02067338
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery
February 18, 2014 updated by: Mahidol University
The Effect of Epidural Low-dose Morphine-soaked Microfibrillar Collagen Sponge in Postoperative Pain Control After Posterior Lumbar Spinal Surgery: a Randomized, Double-blind, Placebo-controlled
The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Siriraj Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 Yrs
- Good orientation and communication
Exclusion Criteria:
- opioids or sulfonamides allergy
- Contraindication for use
- Epidural morphine
- Selective COX 2 inhibitor
- Patient-controlled analgesia (PCA)
- ASA class > 3
- BMI ≥ 35 kg/sq.m.
- Preoperative use of opioids within 6 Wks
- Intraoperative bleeding > 1000ml
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: normal saline
During posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge.
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During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.
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Active Comparator: 1 mg morphine soak in epidural oxidized cellulose
During posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose.
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During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
February 9, 2014
First Submitted That Met QC Criteria
February 18, 2014
First Posted (Estimate)
February 20, 2014
Study Record Updates
Last Update Posted (Estimate)
February 20, 2014
Last Update Submitted That Met QC Criteria
February 18, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Hemostatics
- Coagulants
- Morphine
- Cellulose, Oxidized
Other Study ID Numbers
- SI 387/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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