Hydromorphone and C-section
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydromorphone
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Healthy women undergoing cesarean section
Exclusion Criteria:
- Any comorbidities other than obesity, hypertension, fetal anomalies
Sites / Locations
- Grady Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydromorphone
Arm Description
Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Outcomes
Primary Outcome Measures
Pain Scores, Visual Analogue Pain Scale
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Secondary Outcome Measures
Pain Scores, Visual Analogue Pain Scale
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Pain Scores, Visual Analogue Pain Scale
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Pain Scores, Visual Analogue Pain Scale
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Pain Scores, Visual Analogue Pain Scale
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598545
Brief Title
Hydromorphone and C-section
Official Title
Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydromorphone
Arm Type
Experimental
Arm Description
Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
Primary Outcome Measure Information:
Title
Pain Scores, Visual Analogue Pain Scale
Description
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time Frame
12 hours after intrathecal injection
Secondary Outcome Measure Information:
Title
Pain Scores, Visual Analogue Pain Scale
Description
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time Frame
Baseline
Title
Pain Scores, Visual Analogue Pain Scale
Description
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time Frame
6 hours after intrathecal injection
Title
Pain Scores, Visual Analogue Pain Scale
Description
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time Frame
18 hours after intrathecal injection
Title
Pain Scores, Visual Analogue Pain Scale
Description
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
Time Frame
24 hours after intrathecal injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women undergoing cesarean section
Exclusion Criteria:
Any comorbidities other than obesity, hypertension, fetal anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant C Lynde, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
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Hydromorphone and C-section
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