N/A
N=160
Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02605187 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Opioid Consumption in the 0-48 Hour Study Periods. — 10; 5; 10; 5 milligram morphine equivalents (MMEQ)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- No choice given (Other); Choice given (Other); Ibuprofen (Drug); Acetaminophen (Drug); Gabapentin (Drug); Morphine (low) (Drug); Morphine (med) (Drug); Morphine (high) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption in the 0-48 Hour Study Periods. |
10; 5; 10; 5; 10; 0 | — |
| PRIMARY Pain Scores |
1.6; 1.8; 1.9; 2.2; 3.2; 3.4 | 0.882 |
| SECONDARY Count of Participants Who Need Opioid Use |
27; 14; 50; 13; 23; 8 | 0.311 |
| SECONDARY Count of Participants With Presence of Pruritus |
27; 11; 63; 13; 12; 3 | 0.092 |
| SECONDARY Pruritus Score at 24 and 48 After Delivery |
4.2; 1.7; 3.7; 4.5; 0.8; 0.2 | 0.006 sig |
| SECONDARY Count of Participants Who Need Medical Treatment of Pruritus |
7; 2; 12; 3; 2; 0 | 0.759 |
| SECONDARY Counts of Participants With Presence of Nausea |
11; 7; 33; 10 | 0.281 |
| SECONDARY Nausea Score Score at 24 and 48 After Delivery |
1.3; 1.1; 1.5; 1.8; 0.3; 0.2 | 0.786 |
| SECONDARY Counts of Participants Who Need Medical Treatment for Nausea |
8; 9; 20; 9; 0; 1 | 0.057 |
| SECONDARY Average Number of Vomiting Episodes After Delivery |
0.6; 0.3; 0.5; 1.3; 0; 0 | 0.226 |
| SECONDARY Time to Discharge |
4771.9; 4652.1; 5278.9; 5722.3 | 0.036 sig |
| SECONDARY Patient Overall Satisfaction With Postoperative Analgesia |
87.2; 90.3; 94.1; 93.3; 89.9; 92.6 | 0.019 sig |
Summary
The ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. This study hopes to determine if patient's involvement in analgesic drug/dosage selection can optimize pain relief while minimizing related side effects. This could result in a more patient-centered care model and individualized perioperative analgesic treatment protocols based on patient's preferences, needs and expectations.
Eligibility Criteria
Inclusion Criteria
- Women age 18-50
- Singleton gestation
- Not in active labor
- Scheduled for their 1st, 2nd, or 3rd elective Cesarean
- Cesarean deliveries under spinal or combined spinal epidural anesthesia (with no additional epidural doses administered)
Exclusion Criteria
- History of chronic pain, anxiety, or depression
- Unable to understand the concept of Verbal Numerical Pain Scale at the time of informed consent
- Chronic consumption of opiates, antidepressants or anticonvulsants
- Intake of opioids, NSAIDS or acetaminophen 48hrs prior to the psychophysical test
- Preeclampsia (with any severe features)
- Diabetes (not controlled with diet and needing drugs)
- Preterm delivery (<35 weeks gestation)
Data sourced from ClinicalTrials.gov (NCT02605187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.