Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Pain Clinical Trial

Official title:

Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866254
• Other study ID #: 13527
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2013
• Est. completion date: October 22, 2018

Study information

• Verified date: January 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 22, 2018
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Hydromorphone
Injection of 100 mcg hydromorphone into the intrathecal space
• Morphine
Injection of 200 mcg of intrathecal morphine

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Grace Shih, MD	Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Scores	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	from Baseline to 24 Hours
Secondary	Number of Participants with Adverse Events (AEs)	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.	up to 24 Hours