Intrathecal Hydromorphone for Labor Analgesia

Phase 2

Completed

• Conditions: Labor Pain
• Interventions: Drug: Hydromorphone

• Registration Number: NCT01598506
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Study Start: 2013-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2014-11-04
• Results First Submitted QC: 2014-11-04
• Results First Posted: 2014-11-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Healthy patients
• Labor
• Desires pain relief

Exclusion Criteria

• Any comorbidities other than obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydromorphone	Hydromorphone	Laboring patients receive ED50 of hydromorphone one time intrathecally

Primary Outcome Measures

Name	Time	Method
Pain Score, Visual Analogue Pain Scores	30 minutes after intrathecal injection	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Secondary Outcome Measures

Name	Time	Method
Pain Scores, Visual Analogue Pain Scale	Baseline	Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States