NCT01598506

Brief Summary

This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone. After the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

May 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 10, 2014

Completed
Last Updated

January 12, 2018

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

May 10, 2012

Results QC Date

November 4, 2014

Last Update Submit

December 14, 2017

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Score, Visual Analogue Pain Scores

    Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

    30 minutes after intrathecal injection

Secondary Outcomes (1)

  • Pain Scores, Visual Analogue Pain Scale

    Baseline

Study Arms (1)

Hydromorphone

EXPERIMENTAL

Laboring patients receive ED50 of hydromorphone one time intrathecally

Drug: Hydromorphone

Interventions

HydromorphoneDRUG

Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.

Hydromorphone

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy patients
  • Labor
  • Desires pain relief

You may not qualify if:

  • Any comorbidities other than obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

  • O'Reilly-Shah V, Lynde GC. Determination of ED50 and time to effectiveness for intrathecal hydromorphone in laboring patients using Dixon's up-and-down sequential allocation method. BMC Anesthesiol. 2018 Oct 5;18(1):140. doi: 10.1186/s12871-018-0603-8.

    PMID: 30290794DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Grant Lynde
Organization
Emory University
glynde@emory.edu
404-778-3900

Study Officials

  • Grant C Lynde, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 15, 2012

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 12, 2018

Results First Posted

November 10, 2014

Record last verified: 2017-12

Locations

US(1)