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Pain | Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:HydromorphoneInjection of 100 mcg hydromorphone into the intrathecal space

Drug:MorphineInjection of 200 mcg of intrathecal morphine

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Hydromorphone100 mg, intrathecal administration

Morphine200 mg, intrathecal administration

Study Status

Active, not recruiting

Start Date: May 2013

Completed Date: December 4, 2018

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: Change in Pain Scores

Secondary Outcome: Number of Participants with Adverse Events (AEs)

Study sponsors, principal investigator, and references

Principal Investigator: Grace Shih, MD

Lead Sponsor: Grace Shih, MD

Collaborator: Masimo Corporation

More information:https://clinicaltrials.gov/show/NCT01866254

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