Cesarean Section, Pain
Conditions
Keywords
Intrathecal hydromorphone, Intrathecal morphine, Primary cesarean section, Analgesia
Brief summary
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.
Interventions
DRUGIntrathecal morphine
0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.
50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Fentanyl PCA Consumption | at 24 hours | Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initial PCA Use | up to 24 hours | 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. |
| Pain Score | at 24 hours | Assess pain scores on a scale of 1-5, with higher score indicating more pain. |
| Patient Satisfaction Score | at 24 hours | Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction |
| Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | up to 24 hours | Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in April 2014 with enrollment from May 2014 to May 2017
Participants by arm
| Arm | Count |
|---|---|
| Intrathecal Morphine 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections | 38 |
| Intrathecal Hydromorphone 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. | 37 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | additional surgery | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Intrathecal Morphine | Intrathecal Hydromorphone | Total |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 5.1 | 33.75 years STANDARD_DEVIATION 4.1 | 34.1 years STANDARD_DEVIATION 4.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 37 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 36 / 40 | 35 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Post Operative Fentanyl PCA Consumption
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
Time frame: at 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrathecal Morphine | Post Operative Fentanyl PCA Consumption | 300 µg | Standard Deviation 432 |
| Intrathecal Hydromorphone | Post Operative Fentanyl PCA Consumption | 446 µg | Standard Deviation 440 |
Secondary
Pain Score
Assess pain scores on a scale of 1-5, with higher score indicating more pain.
Time frame: at 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intrathecal Morphine | Pain Score | 4.8 score on a scale |
| Intrathecal Hydromorphone | Pain Score | 4.7 score on a scale |
Secondary
Patient Satisfaction Score
Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction
Time frame: at 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intrathecal Morphine | Patient Satisfaction Score | 4.8 score on a scale |
| Intrathecal Hydromorphone | Patient Satisfaction Score | 4.6 score on a scale |
Secondary
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.
Time frame: up to 24 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intrathecal Morphine | Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Nausea | 4.4 score on a scale |
| Intrathecal Morphine | Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Pruritus | 3.8 score on a scale |
| Intrathecal Hydromorphone | Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Nausea | 4.7 score on a scale |
| Intrathecal Hydromorphone | Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Pruritus | 4 score on a scale |
Secondary
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.
Time frame: up to 24 hours
Population: data not collected.