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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Drug Dose

• Registration Number: NCT01425762
• Lead Sponsor: Stanford University

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.

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

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Exclusion Criteria

• Patient refusal.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No Choice Group	Drug Dose	-
Choice Group	Drug Dose	-

Primary Outcome Measures

Name	Time	Method
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.	up to 6 months

Secondary Outcome Measures

Name	Time	Method
preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery.	Baseline and day 1

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States