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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01425762

Enrollment

120

Registered

2011-08-30

Start date

2011-08-31

Completion date

2013-07-31

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

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.

Interventions

OTHERDrug Dose

100 versus 200 mcg IT morphine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026