Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section
NCT ID: NCT01465191
Last Updated: 2020-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
169 participants
INTERVENTIONAL
2011-11-30
2014-05-31
Brief Summary
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Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most receive a dose of preservative free morphine with the spinal anesthetic. Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.
The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at the 40th amino acid of the protein, with asparagine and asparate being present in different people. The less common variant (aspartate), present in 25-30% of the overall American population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in many studies to affect opioid analgesia.
This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150 micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other genes that may affect pain and analgesic responses. The primary outcome will be the amount of intravenous morphine patients self-administer in the 24 hours postsurgery.
The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.
It is anticipated that there will be an interim data analysis at 150 evaluable subjects for assessment of the dose response to morphine in the overall population; then a final analysis at 300 subjects for the genetic effect assessment.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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50 micrograms (mcg) spinal morphine
Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section
Morphine
Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
100 micrograms spinal morphine
Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section
Morphine
Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
150 micrograms spinal morphine
Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section
Morphine
Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Interventions
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Morphine
Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* analgesic medications
* complications of pregnancy
18 Years
45 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Responsible Party
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Richard M. Smiley
Professr of Clinical Anesthesiology
Principal Investigators
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Richard M Smiley, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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George Washington University Medical Center
Washington D.C., District of Columbia, United States
Columbia University Medical Center
New York, New York, United States
Countries
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Other Identifiers
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AAAI2804
Identifier Type: -
Identifier Source: org_study_id