NCT02143141

Brief Summary

The investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. The investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2017

Completed
Last Updated

September 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

March 27, 2014

Results QC Date

July 20, 2017

Last Update Submit

August 9, 2018

Conditions

Scheduled Cesarean SectionsPostoperative Pain ManagementSide Effects

Keywords

postoperative painnarcotic side effects

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.

    24 hours

Secondary Outcomes (2)

  • Itching

    24 hours

  • Nausea/Vomiting

    24 hours

Study Arms (2)

duramorph

ACTIVE COMPARATOR

duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours

Drug: duramorph

no duramorph

EXPERIMENTAL

no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively

Drug: placebo

Interventions

duramorphDRUG

duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.

Also known as: duramorph versus placebo
duramorph
placeboDRUG

placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.

no duramorph

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anticipated pain level estimated to be in the lowest 20th percentile (calculated \<34.3 utilizing our standard preoperative questionnaire)
  • age \>/= 18
  • not allergic to any study medications to be utilized in this study
  • singleton pregnancy

You may not qualify if:

  • allergies to morphine or acetaminophen
  • diagnosis of a chronic pain disorder
  • weight \>300 lbs
  • hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

Early termination leading to small number of subjects analyzed. Extreme difficulty in recruiting participants to participate in the study.

Results Point of Contact

Title
Dr. Jessica Booth
Organization
Wake Forest School of Medicine
jbooth@wakehealth.edu
3367188278

Study Officials

  • Jessica Booth, MD

    Wake Forest University Health Sciences

    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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

May 20, 2014

Study Start

November 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 10, 2018

Results First Posted

September 25, 2017

Record last verified: 2018-08

Locations

US(1)