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Completed

NCT Number: NCT01866254

Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone

Drug

Injection of 100 mcg hydromorphone into the intrathecal space

Other names: DILAUDID® INJECTION

Morphine

Drug

Injection of 200 mcg of intrathecal morphine

Other names: Duramorph

Primary outcomes

  1. Change in Pain Scores

    Time frame: 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 outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Grace Shih, MD

Other

Collaborators

  • Masimo Corporation

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
May 31, 2013
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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