Hydromorphone and C-section

Study Overview
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Brief Summary
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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.

Official Title
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Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women undergoing cesarean section Exclusion Criteria: Any comorbidities other than obesity, hypertension, fetal anomalies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydromorphone<br>Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally | Drug: Hydromorphone<br>* Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 12 hours after intrathecal injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | Baseline | 
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 6 hours after intrathecal injection | 
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 18 hours after intrathecal injection | 
| Pain Scores, Visual Analogue Pain Scale | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). | 24 hours after intrathecal injection |