Intrathecal Hydromorphone for Labor Analgesia

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598506
• Other study ID #: IRB00054701
• 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
• 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

Related Conditions & MeSH terms

• Labor Pain

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