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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University
ClinicalTrials.gov Identifier:
NCT01425762
First received: August 25, 2011
Last updated: November 19, 2014
Last verified: November 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery. [ Time Frame: Baseline and day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425762

Contacts
Contact: Brendan Carvalho (650) 222-7967 brendan.carvalho@stanford.edu
Contact: Farheen Mirza mirzaf@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Brendan Carvalho       brendan.carvalho@stanford.edu   
Contact: Farheen Mirza       mirzaf@stanford.edu   
Principal Investigator: Brendan Carvalho         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Brendan Carvalho Stanford University
  More Information

No publications provided

Responsible Party: Brendan Carvalho, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01425762     History of Changes
Other Study ID Numbers: SU-08172011-8271, IRB 21802
Study First Received: August 25, 2011
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014