Ignite Creation Date:
2024-05-06 @ 12:00 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01465191
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2011-11-02
Brief Title:
Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Effect of OPRM1 Genotype on the Dose Response to Spinal Morphine for Post-Cesarean Analgesia
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HYPOTHESIS The response to a given dose of morphine given via a spinal anesthetic for cesarean section will be affected by the genetics of the womans mu-opioid receptor
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 geneis 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 nauseavomiting 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
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 geneis 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 nauseavomiting 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None