Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Early Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Hydromorphone; Drug: Morphine

• Registration Number: NCT01866254
• Lead Sponsor: Grace Shih, MD

Brief Summary

The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.

Detailed Description

Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine.

One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Primary Completion: 2017-12-04
• Study Completion: 2018-10-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
• ASA status of I-III
• BMI < 40
• Able to understand and sign informed consent

Exclusion Criteria

• Severe pre-eclampsia
• Conversion to general anesthetic
• History of chronic opioid use
• Allergy to morphine, or hydromorphone
• Hyperemesis gravidarum
• Emergency case
• Patients who have an infection at the intended site of spinal insertion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydromorphone	Hydromorphone	100 mg, intrathecal administration
Morphine	Morphine	200 mg, intrathecal administration

Primary Outcome Measures

Name	Time	Method
Change in Pain Scores	from Baseline to 24 Hours	Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	up to 24 Hours	Patients will be monitored hourly for first 12 hours followed by every 2 hours for the next 12 hours. Masimo acoustic monitor will monitor respirations.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States