NCT01844206

Brief Summary

The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Trial Health

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Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

April 29, 2013

Results QC Date

October 16, 2015

Last Update Submit

November 19, 2015

Conditions

PainMorphine Adverse Reaction

Keywords

Post-cesarean analgesiaSecond dose of epidural morphine after surgeryPost-operative analgesiaSelf-administered epidural morphinePain management after cesarean

Outcome Measures

Primary Outcomes (1)

  • The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery

    The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.

    Up to 48 hours post-operatively

Study Arms (2)

Epidural Morphine

ACTIVE COMPARATOR

Group receiving 3mg epidural morphine, 24 hours after the initial dose

Drug: Epidural Morphine

Epidural Saline

PLACEBO COMPARATOR

Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.

Drug: Epidural Saline

Interventions

Epidural MorphineDRUG

Patients will be given 3mg epidural morphine, 24 hours after the initial dose.

Also known as: DepoDur
Epidural Morphine
Epidural SalineDRUG

Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.

Also known as: Sodium Chloride Solution
Epidural Saline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing cesarean section under epidural anesthesia.

You may not qualify if:

  • Emergent cesarean section
  • Coagulopathy
  • Failed epidural anesthesia or patchy block
  • General anesthesia
  • Use of epidural chloroprocaine
  • Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
  • Severe opioid side effects
  • History of chronic opioid use
  • History of chronic pain
  • History of obstructive sleep apnea
  • Morbid obesity (Body Mass Index (BMI)\>45 kg/m2)
  • Height under 4' 10" (147 cm)
  • Documented dural puncture by the epidural (Tuohy) needle
  • Preeclampsia
  • Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (2)

  • Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.

    PMID: 8213024BACKGROUND

  • Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.

    PMID: 10735794BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. Allison Lee
Organization
Columbia University
al3196@cumc.columbia.edu
305-582-6077

Study Officials

  • Allison Lee, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 23, 2015

Results First Posted

December 23, 2015

Record last verified: 2015-11

Locations

US(1)