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

Stanford University

Status: Completed

Conditions: Pain

Treatments: Other: Drug Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01425762

IRB 21802 (Other Identifier)

SU-08172011-8271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Choice Group

Experimental group

Treatment:

Other: Drug Dose

No Choice Group

Active Comparator group

Treatment:

Other: Drug Dose