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Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425762
First Posted: August 30, 2011
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University
  Purpose
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.

Condition Intervention
Pain Other: Drug Dose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.

Resource links provided by NLM:


Further study details as provided by Brendan Carvalho, Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery. [ Time Frame: Baseline and day 1 ]

Estimated Enrollment: 120
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Choice Group Other: Drug Dose
100 versus 200 mcg IT morphine
Active Comparator: No Choice Group Other: Drug Dose
100 versus 200 mcg IT morphine

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women age 18-50 with singleton, term gestation fetuses and scheduled for their 1st, 2nd, or 3rd elective CS (not in labor) will be included.

Exclusion Criteria:

  • Patient refusal.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01425762


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Brendan Carvalho Stanford University
  More Information

Responsible Party: Brendan Carvalho, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01425762     History of Changes
Other Study ID Numbers: SU-08172011-8271
IRB 21802 ( Other Identifier: Stanford University IRB )
First Submitted: August 25, 2011
First Posted: August 30, 2011
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents