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?
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
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
Start Date: May 2013
Completed Date: December 2017
Phase: Early Phase 1
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