DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Intrathecal Hydromorphone for Labor Analgesia

Information source: Emory University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Labor Pain

Intervention: Hydromorphone (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Grant C Lynde, MD, Principal Investigator, Affiliation: Emory University

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 3 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.

Clinical Details

Official title: Determination of the ED50 of Intrathecal Hydromorphone in Laboring Women Using the Up-and-down Sequential Allocation Method

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain relief

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy patients

- Labor

- Desires pain relief

Exclusion Criteria:

- Any comorbidities other than obesity

Locations and Contacts

Grady Memorial Hospital, Atlanta, Georgia 30303, United States; Not yet recruiting
Grant C Lynde, MD, Phone: 404-616-1000, Email: glynde@emory.edu
Grant C Lynde, MD, Principal Investigator
Additional Information

Starting date: August 2012
Last updated: May 14, 2012

Page last updated: February 07, 2013

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012