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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01598506
Other study ID # IRB00054701
Secondary ID
Status Completed
Phase Phase 2
First received May 10, 2012
Last updated December 14, 2017
Start date September 2013
Est. completion date February 2014

Study information

Verified date December 2017
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy patients

- Labor

- Desires pain relief

Exclusion Criteria:

- Any comorbidities other than obesity

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Grady Memorial Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain Scores, Visual Analogue Pain Scale Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). Baseline
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