Two Dose Epidural Morphine for Post-cesarean Analgesia
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|ClinicalTrials.gov Identifier: NCT01844206|
Recruitment Status : Terminated (Slow recruitment of subjects)
First Posted : May 1, 2013
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain Morphine Adverse Reaction||Drug: Epidural Morphine Drug: Epidural Saline||Phase 4|
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.
The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Two Dose Epidural Morphine for Post-cesarean Analgesia|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: Epidural Morphine
Group receiving 3mg epidural morphine, 24 hours after the initial dose
Drug: Epidural Morphine
Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
Other Name: DepoDur
Placebo Comparator: Epidural Saline
Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Drug: Epidural Saline
Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Other Name: Sodium Chloride Solution
- The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery [ Time Frame: Up to 48 hours post-operatively ]The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844206
|United States, New York|
|New York Presbyterian Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Allison Lee, MD||Columbia University|