NCT01425762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

August 25, 2011

Last Update Submit

November 10, 2015

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery.

    Baseline and day 1

Study Arms (2)

Choice Group

EXPERIMENTAL
Other: Drug Dose

No Choice Group

ACTIVE COMPARATOR
Other: Drug Dose

Interventions

Drug DoseOTHER

100 versus 200 mcg IT morphine

Choice GroupNo Choice Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 28486595DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brendan Carvalho

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 30, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

US(1)