Opioid Use, Pain, Postoperative
Conditions
Keywords
postpartum
Brief summary
Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid
Detailed description
Women will be approached priors to discharge from the hospital, if they meet inclusion criteria and consent for the study, they will be randomized to one of two possible analgesic regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain level.
Interventions
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* English or Spanish speaker women who had a cesarean section
Exclusion criteria
* Inability or refusal to provide informed consent. * Reported current or prior opioid or benzodiazepine use disorder, including urine drug screen positive for a non prescribed opioid or benzodiazepine upon admission or during prenatal care. * Current treatment with methadone, buprenorphine or buprenorphine plus naloxone. * Known alcoholism disorder. * Severe renal or hepatic impairment. * Known creatinine \> 1.5 at the time of delivery or severe proteinuria leading to diagnosis of renal disease prior to delivery. * Severe peptic ulcer disease * Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be allowed to participate) * Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status. * Allergy to any of the study drugs (anaphylaxis). * Incarcerated or institutionalized patients. * Inability to follow up as outpatient in our outpatient clinic. * wound dehiscence or infection diagnosed prior to discharge from the hospital * wound vac placed prior to discharge from the hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | 2-4 weeks postpartum | pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean less pain and a point towards the right will mean more pain. After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 2-4 weeks postpartum | patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied) |
Countries
United States
Participant flow
Recruitment details
recruitment start date: 12/2017 recruitment end date: 03/2018
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Plus Acetaminophen women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen
Ibuprofen: NSAID
Acetaminophen: analgesic
85 women recruited into this study arm | 85 |
| Ibuprofen Plus Acetaminophen/Hydrocodone women that had a C-section will be discharged home with prescriptions for ibuprofen and acetaminophen/hydrocodone
Ibuprofen: NSAID
Acetaminophen plus hydrocodone: Opioid
85 women recruited into this study arm | 85 |
| Total | 170 |
Baseline characteristics
| Characteristic | Ibuprofen Plus Acetaminophen | Ibuprofen Plus Acetaminophen/Hydrocodone | Total |
|---|---|---|---|
| Age, Continuous | 28.39 years STANDARD_DEVIATION 5.8 | 28.05 years STANDARD_DEVIATION 5.64 | 28.2 years STANDARD_DEVIATION 5.7 |
| Race/Ethnicity, Customized Race African american | 36 Participants | 49 Participants | 85 Participants |
| Race/Ethnicity, Customized Race Hispanic | 34 Participants | 29 Participants | 63 Participants |
| Race/Ethnicity, Customized Race other | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Race white | 13 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Female | 85 Participants | 85 Participants | 170 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 / 85 | 0 / 85 |
| other Total, other adverse events | 14 / 85 | 25 / 85 |
| serious Total, serious adverse events | 0 / 85 | 0 / 85 |
Outcome results
Primary
Pain Level
pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean less pain and a point towards the right will mean more pain. After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.
Time frame: 2-4 weeks postpartum
Population: The primary outcome was available in 71 patients in the non-opioid group and 76 patients in the opioid group. The results below are primary outcome data analyzed by intention to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen Plus Acetaminophen | Pain Level | 12.3 millimeters on a scale | Standard Deviation 19.5 |
| Ibuprofen Plus Acetaminophen/Hydrocodone | Pain Level | 15.9 millimeters on a scale | Standard Deviation 20.4 |
Comparison: Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.95% CI: [-2.1, 11.9]
Secondary
Patient Satisfaction
patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)
Time frame: 2-4 weeks postpartum
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibuprofen Plus Acetaminophen | Patient Satisfaction | 2(somewhat dissatisfied) | 3 Participants |
| Ibuprofen Plus Acetaminophen | Patient Satisfaction | 4(satisfied) | 23 Participants |
| Ibuprofen Plus Acetaminophen | Patient Satisfaction | 3(neutral) | 11 Participants |
| Ibuprofen Plus Acetaminophen | Patient Satisfaction | 5(very satisfied) | 37 Participants |
| Ibuprofen Plus Acetaminophen | Patient Satisfaction | 1(very dissatisfied) | 2 Participants |
| Ibuprofen Plus Acetaminophen/Hydrocodone | Patient Satisfaction | 5(very satisfied) | 46 Participants |
| Ibuprofen Plus Acetaminophen/Hydrocodone | Patient Satisfaction | 1(very dissatisfied) | 4 Participants |
| Ibuprofen Plus Acetaminophen/Hydrocodone | Patient Satisfaction | 2(somewhat dissatisfied) | 3 Participants |
| Ibuprofen Plus Acetaminophen/Hydrocodone | Patient Satisfaction | 3(neutral) | 12 Participants |
| Ibuprofen Plus Acetaminophen/Hydrocodone | Patient Satisfaction | 4(satisfied) | 16 Participants |