Hydromorphone and C-section
Information source: Emory University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Hydromorphone (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Emory University
This study will investigate the dose of hydromorphone which will relieve the pain of women
following a cesarean section when delivered directly in the area around the spinal cord
(i. e., intrathecal injection). The primary objective is to determine the dose of intrathecal
hydromorphone that results in a pain score of less than 3 out of 10 12 hours after
intrathecal injection in 50% of women. Secondary objectives include determining the average
amount of time patients obtain pain relief after injection. Other secondary objectives
include determining the frequency and severity of side-effects associated with intrathecal
administration of hydromorphone, including: bradycardia, hypotension, respiratory
depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted
to labor and delivery for planned cesarean section desiring will be consented for the study.
The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential
allocation method of statistical analysis will be used, meaning that each subsequent dose
will be dependent upon the result obtained from the prior dose - ergo, if the initial
subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the
initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg
more) of hydromorphone.
After the intrathecal injection is given, patients will undergo their cesarean section. The
patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire.
The patient's medical record will be reviewed to determine when she first requested
supplemental pain medication. A pain score of less than three will be a positive result. A
pain score of three or greater will be a negative result. Blood pressure, heart rate,
arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be
Official title: Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Postoperative Pain Relief
Minimum age: 18 Years.
Maximum age: 40 Years.
- Healthy women undergoing cesarean section
- Any comorbidities other than obesity, hypertension, fetal anomalies
Locations and Contacts
Starting date: August 2012
Last updated: May 14, 2012