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

NCT ID: NCT01425762

Last Updated: 2015-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Choice Group

Group Type EXPERIMENTAL

Drug Dose

Intervention Type OTHER

100 versus 200 mcg IT morphine

No Choice Group

Group Type ACTIVE_COMPARATOR

Drug Dose

Intervention Type OTHER

100 versus 200 mcg IT morphine

Interventions

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Drug Dose

100 versus 200 mcg IT morphine

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Brendan Carvalho

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brendan Carvalho

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Carvalho B, Mirza F, Flood P. Patient choice compared with no choice of intrathecal morphine dose for caesarean analgesia: a randomized clinical trial. Br J Anaesth. 2017 May 1;118(5):762-771. doi: 10.1093/bja/aex039.

Reference Type DERIVED
PMID: 28486595 (View on PubMed)

Other Identifiers

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IRB 21802

Identifier Type: OTHER

Identifier Source: secondary_id

SU-08172011-8271

Identifier Type: -

Identifier Source: org_study_id

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