Intrathecal Hydromorphone for Pain Control After Cesarean Section

Study Overview
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Brief Summary
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The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery. Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting. Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section. In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.

Official Title
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Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Conditions
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Pain, Cesarean Section

Intervention / Treatment
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* Drug: Intrathecal morphine
* Drug: Intrathecal hydromorphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective primary cesarean section Females age 18-40 Exclusion Criteria: Emergency cesarean section Anesthetic other than spinal History of chronic pain or pre-op opioid use Allergy to morphine or hydromorphone BMI>40

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal morphine<br>0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections | Drug: Intrathecal morphine<br>* 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.<br>* Other names: Duramorph;|
| Experimental: Intrathecal hydromorphone<br>50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. | Drug: Intrathecal hydromorphone<br>* 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.<br>* Other names: Dilaudid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Fentanyl PCA Consumption | Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op. | at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Initial PCA Use | When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia. | up to 24 hours | 
| Pain Score | Assess pain scores on a scale of 1-5, with higher score indicating more pain. | at 24 hours | 
| Patient Satisfaction Score | Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction | at 24 hours | 
| Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms. | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrathecal hydromorphone, Intrathecal morphine, Primary cesarean section, Analgesia