Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.
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| First Received Date ICMJE | August 25, 2011 | ||||||||
| Last Updated Date | June 8, 2012 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
pain scores (0-10) and analgesic use (morphine mg-equivalents) between the groups that have analgesic choice vs. no choice and among the actual doses received. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01425762 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery. [ Time Frame: Baseline and day 1 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain. | ||||||||
| Official Title ICMJE | Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain. | ||||||||
| Brief Summary | This is a randomized controlled study that will place patients into a "choice" and a "no choice" group. The choice group will be able to choose between receiving 100 mcg or 200 mcg intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200 mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3, 6, 12, 24, and 36 hours. |
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| Detailed Description | This randomised controlled study will include pre-operative screening with a 2 simple questionnaires and the patient will be randomised into a "choice" and "no choice" groups. The group with the choice will be offered 2 different doses of intrathecal morphine (100, 200 mcg) which they can decide on after being given a standard script explaining advantages and disadvantages of each dose. Following cesarean section patients will be followed up at 3, 6, 12, 24, 36, 48 hours following spinal injection to assess severity of pain, time to first analgesia, total analgesia requirements, treatment of nausea, vomiting and pruritus. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE | Other: Drug Dose
100 versus 200 mcg IT morphine |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01425762 | ||||||||
| Other Study ID Numbers ICMJE | SU-08172011-8271, IRB 21802 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Brendan Carvalho, Stanford University | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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