Postoperative Pain
Conditions
Keywords
cesarean, postoperative pain, patient choice
Brief 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.
Detailed description
This randomized, controlled study will include a simple, preoperative questionnaire to obtain baseline demographic and obstetric data; and complete questions (that have previously been shown to be predictive of postoperative pain) from which we will determine their expected and target postoperative pain scores. These questionnaires should take less than 3-4 minutes to complete. The subject will then be randomized into choice and no choice groups. The randomization for choice vs. no choice will be at a 1:3 ratio i.e. 1 woman will get no choice and 3 will get a choice for their analgesic protocol. All women will receive the same medications for intraoperative anesthetic management -- only the postoperative pain medications will be altered. The no choice group will receive the current standard analgesic protocol: medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. The group with the choice will be offered 3 different protocols: 1\. low dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 2 medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 3. high dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h, as well as gabapentin po one time within 1 hr of delivery. Women randomized to the choice group will select a protocol after being given a standard script explaining advantages and disadvantages of each protocol. Drugs and doses utilized in the study are safe for postpartum women and within dose range routinely used at our and other institutions. All breakthrough pain will be managed the same for all patients, and adequate analgesia will be available to treat post-operative pain. Primary breakthrough rescue analgesic will be our standard oral opioid oxycodone managed using our current treatment algorithm. If pain 1-4 out of 10, 1 tablet (5 mg) will be offered, if pain \>4 out of 10, 2 tablets (10 mg) will be offered PRN. Pain not responding to oral opioids will be offered IV morphine boluses or PCA as per standard treatment protocols. Additional analgesic options (e.g. TAP blocks) will also be available as per standard care. Following standard Cesarean delivery, postoperative data will be collected (directly from patients and from the electronic medical record) by study investigators blinded to group assignment. Outcome measures: 1. Pain scores at rest and on to sitting (VPS 0-10) collected at 3, 6, 12, 24, 36, 48 hours post-cesarean 2. Overall daily pain score and its deviation from target and expected pain score will be determined at 0-24 and \>24-48 hours study periods. 3. Opioid use (oral and IV morphine) in the 0-24 and \>24-48 hour study periods. 4. Time to first analgesic for breakthrough pain (minutes from spinal) 5. Side effect: Pruritus score (0-100), nausea score (0-100) and number of episodes of vomiting for the 0-24 and \>24-48 hour post- operative periods 6. Any treatment of pruritus and/or nausea/vomiting 7. Satisfaction with postoperative analgesia score (0-100) 8. Discharge time (hours/minutes from surgery end) Telephone follow-up for pain score, opioid use, and functional recovery will be performed at 1 week, 1 month, 3 months and 6 months post-Cesarean. The telephonic questions will last 3-4 minutes
Interventions
Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen 600mg po q6h
Acetaminophen 650mg po q6h
Gabapentin 600mg po one time within 1 hour of delivery
Intrathecal morphine dose 50mcg
Intrathecal morphine dose 150mcg
Intrathecal morphine 300mcg
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in the 0-48 Hour Study Periods. | 0-24 and 24-48 hour postoperative periods | Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods. |
| Pain Scores | 3, 6, 12, 24, 36 and 48 hours after delivery | Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus Score at 24 and 48 After Delivery | 24 and 48 hours following delivery | Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching. |
| Count of Participants Who Need Medical Treatment of Pruritus | 0-24 and 24-48 hours after delivery | Count of participants who need medical treatment of pruritus during first 48 hours after delivery. |
| Counts of Participants With Presence of Nausea | 0-48 hours after delivery | Count of participants with nausea through 48 hours after delivery. |
| Nausea Score Score at 24 and 48 After Delivery | 0-24 and 24-48 hours after delivery | Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea. |
| Count of Participants Who Need Opioid Use | 0-24 and 24-48 hours after delivery | Count of participants who need opioid use through 48 hours after delivery. |
| Average Number of Vomiting Episodes After Delivery | 0-24 and 24-48 hours after delivery | — |
| Time to Discharge | Delivery through discharge (average 4 days) | Minutes from delivery until discharge. |
| Patient Overall Satisfaction With Postoperative Analgesia | 24 and 48 hours after delivery | Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied. |
| Counts of Participants Who Need Medical Treatment for Nausea | 0-24 and 24-48 hours after delivery | Counts of participants who need medical treatment of nausea through 48 hours after delivery. |
| Count of Participants With Presence of Pruritus | 0-24 and 24-48 hours after delivery | Count of participants with pruritus through 48 hours after delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Choice No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg | 32 |
| Choice: Low Protocol Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg | 19 |
| Choice: Medium Protocol Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg | 72 |
| Choice: High Protocol Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg | 15 |
| Total | 138 |
Baseline characteristics
| Characteristic | No Choice | Choice: Low Protocol | Choice: Medium Protocol | Choice: High Protocol | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35 years | 37 years | 34 years | 33 years | 35 years |
| Body Mass Index (BMI) | 28 kg/m^2 | 28 kg/m^2 | 29 kg/m^2 | 30 kg/m^2 | 28 kg/m^2 |
| Education BA or equivalent | 10 Participants | 3 Participants | 28 Participants | 6 Participants | 47 Participants |
| Education Graduate Degree | 13 Participants | 14 Participants | 33 Participants | 5 Participants | 65 Participants |
| Education High school | 4 Participants | 1 Participants | 3 Participants | 2 Participants | 10 Participants |
| Education Some college | 5 Participants | 1 Participants | 8 Participants | 2 Participants | 16 Participants |
| Gestational age (week) | 39.0 week | 39.1 week | 39.0 week | 39.0 week | 39.0 week |
| Language English | 27 Participants | 19 Participants | 66 Participants | 11 Participants | 123 Participants |
| Language Other | 5 Participants | 0 Participants | 6 Participants | 4 Participants | 15 Participants |
| Nulliparous | 4 Participants | 6 Participants | 16 Participants | 3 Participants | 29 Participants |
| Previous Cesarean Delivery | 21 Participants | 15 Participants | 45 Participants | 10 Participants | 91 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 7 Participants | 27 Participants | 3 Participants | 46 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants | 11 Participants | 42 Participants | 11 Participants | 83 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Female | 32 Participants | 19 Participants | 72 Participants | 15 Participants | 138 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 19 | 0 / 72 | 0 / 15 |
| other Total, other adverse events | 3 / 32 | 1 / 19 | 6 / 72 | 3 / 15 |
| serious Total, serious adverse events | 0 / 32 | 0 / 19 | 0 / 72 | 0 / 15 |
Outcome results
Opioid Consumption in the 0-48 Hour Study Periods.
Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Time frame: 0-24 and 24-48 hour postoperative periods
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Choice | Opioid Consumption in the 0-48 Hour Study Periods. | 24-48 hours | 10 milligram morphine equivalents (MMEQ) |
| No Choice | Opioid Consumption in the 0-48 Hour Study Periods. | 0-24 hours | 10 milligram morphine equivalents (MMEQ) |
| Choice: Low Protocol | Opioid Consumption in the 0-48 Hour Study Periods. | 0-24 hours | 5 milligram morphine equivalents (MMEQ) |
| Choice: Low Protocol | Opioid Consumption in the 0-48 Hour Study Periods. | 24-48 hours | 0 milligram morphine equivalents (MMEQ) |
| Choice: Medium Protocol | Opioid Consumption in the 0-48 Hour Study Periods. | 24-48 hours | 5 milligram morphine equivalents (MMEQ) |
| Choice: Medium Protocol | Opioid Consumption in the 0-48 Hour Study Periods. | 0-24 hours | 10 milligram morphine equivalents (MMEQ) |
| Choice: High Protocol | Opioid Consumption in the 0-48 Hour Study Periods. | 24-48 hours | 30 milligram morphine equivalents (MMEQ) |
| Choice: High Protocol | Opioid Consumption in the 0-48 Hour Study Periods. | 0-24 hours | 5 milligram morphine equivalents (MMEQ) |
Pain Scores
Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.
Time frame: 3, 6, 12, 24, 36 and 48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Choice | Pain Scores | Pain at rest tat 36 hours | 1.5 units on a scale | Standard Deviation 1.6 |
| No Choice | Pain Scores | Pain at movement at 6 hours | 4.0 units on a scale | Standard Deviation 2.7 |
| No Choice | Pain Scores | Pain at rest at 6 hours | 2.3 units on a scale | Standard Deviation 2.3 |
| No Choice | Pain Scores | Pain at movement at 3 hours | 3.2 units on a scale | Standard Deviation 2.9 |
| No Choice | Pain Scores | Pain at movement at 48 hours | 3.5 units on a scale | Standard Deviation 1.9 |
| No Choice | Pain Scores | Pain at movement at 24 hours | 4.5 units on a scale | Standard Deviation 2.3 |
| No Choice | Pain Scores | Pain at rest at 24 hours | 2.2 units on a scale | Standard Deviation 1.9 |
| No Choice | Pain Scores | Pain at movement at 36 hours | 3.5 units on a scale | Standard Deviation 2.2 |
| No Choice | Pain Scores | Pain at rest at 48 hours | 1.7 units on a scale | Standard Deviation 1.6 |
| No Choice | Pain Scores | Pain at movement at 12 hours | 3.0 units on a scale | Standard Deviation 2.3 |
| No Choice | Pain Scores | Pain at rest at 12 hours | 1.5 units on a scale | Standard Deviation 1.7 |
| No Choice | Pain Scores | Pain at rest at 3 hours | 1.6 units on a scale | Standard Deviation 2 |
| Choice: Low Protocol | Pain Scores | Pain at movement at 24 hours | 4.1 units on a scale | Standard Deviation 1.5 |
| Choice: Low Protocol | Pain Scores | Pain at rest tat 36 hours | 1.7 units on a scale | Standard Deviation 1.3 |
| Choice: Low Protocol | Pain Scores | Pain at movement at 36 hours | 4.0 units on a scale | Standard Deviation 2.1 |
| Choice: Low Protocol | Pain Scores | Pain at rest at 3 hours | 1.8 units on a scale | Standard Deviation 2 |
| Choice: Low Protocol | Pain Scores | Pain at movement at 3 hours | 3.4 units on a scale | Standard Deviation 2.5 |
| Choice: Low Protocol | Pain Scores | Pain at rest at 6 hours | 2.7 units on a scale | Standard Deviation 1.9 |
| Choice: Low Protocol | Pain Scores | Pain at movement at 6 hours | 4.4 units on a scale | Standard Deviation 2.4 |
| Choice: Low Protocol | Pain Scores | Pain at rest at 12 hours | 2.1 units on a scale | Standard Deviation 1.7 |
| Choice: Low Protocol | Pain Scores | Pain at movement at 12 hours | 4.7 units on a scale | Standard Deviation 1.5 |
| Choice: Low Protocol | Pain Scores | Pain at rest at 24 hours | 1.9 units on a scale | Standard Deviation 1 |
| Choice: Low Protocol | Pain Scores | Pain at rest at 48 hours | 2.0 units on a scale | Standard Deviation 1.9 |
| Choice: Low Protocol | Pain Scores | Pain at movement at 48 hours | 3.9 units on a scale | Standard Deviation 1.8 |
| Choice: Medium Protocol | Pain Scores | Pain at rest at 48 hours | 2.0 units on a scale | Standard Deviation 1.6 |
| Choice: Medium Protocol | Pain Scores | Pain at movement at 6 hours | 3.8 units on a scale | Standard Deviation 2.4 |
| Choice: Medium Protocol | Pain Scores | Pain at rest at 12 hours | 1.9 units on a scale | Standard Deviation 1.8 |
| Choice: Medium Protocol | Pain Scores | Pain at movement at 36 hours | 4.5 units on a scale | Standard Deviation 2 |
| Choice: Medium Protocol | Pain Scores | Pain at movement at 24 hours | 4.3 units on a scale | Standard Deviation 2 |
| Choice: Medium Protocol | Pain Scores | Pain at movement at 12 hours | 3.6 units on a scale | Standard Deviation 2 |
| Choice: Medium Protocol | Pain Scores | Pain at rest at 24 hours | 2.2 units on a scale | Standard Deviation 1.7 |
| Choice: Medium Protocol | Pain Scores | Pain at rest tat 36 hours | 2.6 units on a scale | Standard Deviation 2 |
| Choice: Medium Protocol | Pain Scores | Pain at movement at 3 hours | 3.2 units on a scale | Standard Deviation 2.7 |
| Choice: Medium Protocol | Pain Scores | Pain at movement at 48 hours | 3.6 units on a scale | Standard Deviation 1.8 |
| Choice: Medium Protocol | Pain Scores | Pain at rest at 6 hours | 2.2 units on a scale | Standard Deviation 1.8 |
| Choice: Medium Protocol | Pain Scores | Pain at rest at 3 hours | 1.9 units on a scale | Standard Deviation 2.1 |
| Choice: High Protocol | Pain Scores | Pain at movement at 48 hours | 4.8 units on a scale | Standard Deviation 2.5 |
| Choice: High Protocol | Pain Scores | Pain at movement at 3 hours | 4.1 units on a scale | Standard Deviation 2.5 |
| Choice: High Protocol | Pain Scores | Pain at movement at 6 hours | 3.8 units on a scale | Standard Deviation 2.4 |
| Choice: High Protocol | Pain Scores | Pain at movement at 36 hours | 4.8 units on a scale | Standard Deviation 1.8 |
| Choice: High Protocol | Pain Scores | Pain at rest at 48 hours | 3.3 units on a scale | Standard Deviation 2.2 |
| Choice: High Protocol | Pain Scores | Pain at rest at 24 hours | 2.3 units on a scale | Standard Deviation 1.7 |
| Choice: High Protocol | Pain Scores | Pain at rest at 12 hours | 1.7 units on a scale | Standard Deviation 1.7 |
| Choice: High Protocol | Pain Scores | Pain at rest at 3 hours | 2.2 units on a scale | Standard Deviation 2.2 |
| Choice: High Protocol | Pain Scores | Pain at movement at 24 hours | 3.6 units on a scale | Standard Deviation 1.8 |
| Choice: High Protocol | Pain Scores | Pain at rest at 6 hours | 1.5 units on a scale | Standard Deviation 1.6 |
| Choice: High Protocol | Pain Scores | Pain at movement at 12 hours | 3.2 units on a scale | Standard Deviation 2.1 |
| Choice: High Protocol | Pain Scores | Pain at rest tat 36 hours | 3.1 units on a scale | Standard Deviation 2.4 |
Average Number of Vomiting Episodes After Delivery
Time frame: 0-24 and 24-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Choice | Average Number of Vomiting Episodes After Delivery | 24-48 hours after delivery | 0 vomiting episodes | Standard Deviation 0 |
| No Choice | Average Number of Vomiting Episodes After Delivery | 0-24 hours after delivery | 0.6 vomiting episodes | Standard Deviation 1.5 |
| Choice: Low Protocol | Average Number of Vomiting Episodes After Delivery | 0-24 hours after delivery | 0.3 vomiting episodes | Standard Deviation 1 |
| Choice: Low Protocol | Average Number of Vomiting Episodes After Delivery | 24-48 hours after delivery | 0 vomiting episodes | Standard Deviation 0 |
| Choice: Medium Protocol | Average Number of Vomiting Episodes After Delivery | 0-24 hours after delivery | 0.5 vomiting episodes | Standard Deviation 1.4 |
| Choice: Medium Protocol | Average Number of Vomiting Episodes After Delivery | 24-48 hours after delivery | 0 vomiting episodes | Standard Deviation 0 |
| Choice: High Protocol | Average Number of Vomiting Episodes After Delivery | 24-48 hours after delivery | 0 vomiting episodes | Standard Deviation 0 |
| Choice: High Protocol | Average Number of Vomiting Episodes After Delivery | 0-24 hours after delivery | 1.3 vomiting episodes | Standard Deviation 2 |
Count of Participants Who Need Medical Treatment of Pruritus
Count of participants who need medical treatment of pruritus during first 48 hours after delivery.
Time frame: 0-24 and 24-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Choice | Count of Participants Who Need Medical Treatment of Pruritus | 0-24 hours after delivery | 7 Participants |
| No Choice | Count of Participants Who Need Medical Treatment of Pruritus | 24-48 hours after delivery | 2 Participants |
| Choice: Low Protocol | Count of Participants Who Need Medical Treatment of Pruritus | 24-48 hours after delivery | 0 Participants |
| Choice: Low Protocol | Count of Participants Who Need Medical Treatment of Pruritus | 0-24 hours after delivery | 2 Participants |
| Choice: Medium Protocol | Count of Participants Who Need Medical Treatment of Pruritus | 0-24 hours after delivery | 12 Participants |
| Choice: Medium Protocol | Count of Participants Who Need Medical Treatment of Pruritus | 24-48 hours after delivery | 2 Participants |
| Choice: High Protocol | Count of Participants Who Need Medical Treatment of Pruritus | 0-24 hours after delivery | 3 Participants |
| Choice: High Protocol | Count of Participants Who Need Medical Treatment of Pruritus | 24-48 hours after delivery | 0 Participants |
Count of Participants Who Need Opioid Use
Count of participants who need opioid use through 48 hours after delivery.
Time frame: 0-24 and 24-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Choice | Count of Participants Who Need Opioid Use | 0-24 hours after delivery | 27 Participants |
| No Choice | Count of Participants Who Need Opioid Use | 24-48 hours after delivery | 23 Participants |
| Choice: Low Protocol | Count of Participants Who Need Opioid Use | 24-48 hours after delivery | 8 Participants |
| Choice: Low Protocol | Count of Participants Who Need Opioid Use | 0-24 hours after delivery | 14 Participants |
| Choice: Medium Protocol | Count of Participants Who Need Opioid Use | 0-24 hours after delivery | 50 Participants |
| Choice: Medium Protocol | Count of Participants Who Need Opioid Use | 24-48 hours after delivery | 42 Participants |
| Choice: High Protocol | Count of Participants Who Need Opioid Use | 0-24 hours after delivery | 13 Participants |
| Choice: High Protocol | Count of Participants Who Need Opioid Use | 24-48 hours after delivery | 14 Participants |
Count of Participants With Presence of Pruritus
Count of participants with pruritus through 48 hours after delivery.
Time frame: 0-24 and 24-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Choice | Count of Participants With Presence of Pruritus | 0-24 hours after delivery | 27 Participants |
| No Choice | Count of Participants With Presence of Pruritus | 24-48 hours after delivery | 12 Participants |
| Choice: Low Protocol | Count of Participants With Presence of Pruritus | 24-48 hours after delivery | 3 Participants |
| Choice: Low Protocol | Count of Participants With Presence of Pruritus | 0-24 hours after delivery | 11 Participants |
| Choice: Medium Protocol | Count of Participants With Presence of Pruritus | 0-24 hours after delivery | 63 Participants |
| Choice: Medium Protocol | Count of Participants With Presence of Pruritus | 24-48 hours after delivery | 29 Participants |
| Choice: High Protocol | Count of Participants With Presence of Pruritus | 0-24 hours after delivery | 13 Participants |
| Choice: High Protocol | Count of Participants With Presence of Pruritus | 24-48 hours after delivery | 7 Participants |
Counts of Participants Who Need Medical Treatment for Nausea
Counts of participants who need medical treatment of nausea through 48 hours after delivery.
Time frame: 0-24 and 24-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Choice | Counts of Participants Who Need Medical Treatment for Nausea | 0-24 hours after delivery | 8 Participants |
| No Choice | Counts of Participants Who Need Medical Treatment for Nausea | 24-48 hours after delivery | 0 Participants |
| Choice: Low Protocol | Counts of Participants Who Need Medical Treatment for Nausea | 24-48 hours after delivery | 1 Participants |
| Choice: Low Protocol | Counts of Participants Who Need Medical Treatment for Nausea | 0-24 hours after delivery | 9 Participants |
| Choice: Medium Protocol | Counts of Participants Who Need Medical Treatment for Nausea | 0-24 hours after delivery | 20 Participants |
| Choice: Medium Protocol | Counts of Participants Who Need Medical Treatment for Nausea | 24-48 hours after delivery | 0 Participants |
| Choice: High Protocol | Counts of Participants Who Need Medical Treatment for Nausea | 0-24 hours after delivery | 9 Participants |
| Choice: High Protocol | Counts of Participants Who Need Medical Treatment for Nausea | 24-48 hours after delivery | 0 Participants |
Counts of Participants With Presence of Nausea
Count of participants with nausea through 48 hours after delivery.
Time frame: 0-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Choice | Counts of Participants With Presence of Nausea | 11 Participants |
| Choice: Low Protocol | Counts of Participants With Presence of Nausea | 7 Participants |
| Choice: Medium Protocol | Counts of Participants With Presence of Nausea | 33 Participants |
| Choice: High Protocol | Counts of Participants With Presence of Nausea | 10 Participants |
Nausea Score Score at 24 and 48 After Delivery
Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea.
Time frame: 0-24 and 24-48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Choice | Nausea Score Score at 24 and 48 After Delivery | 0-24 hours after delivery | 1.3 units on a scale | Standard Deviation 2.4 |
| No Choice | Nausea Score Score at 24 and 48 After Delivery | 24-48 hours after delivery | 0.3 units on a scale | Standard Deviation 0.9 |
| Choice: Low Protocol | Nausea Score Score at 24 and 48 After Delivery | 24-48 hours after delivery | 0.2 units on a scale | Standard Deviation 0.5 |
| Choice: Low Protocol | Nausea Score Score at 24 and 48 After Delivery | 0-24 hours after delivery | 1.1 units on a scale | Standard Deviation 2 |
| Choice: Medium Protocol | Nausea Score Score at 24 and 48 After Delivery | 0-24 hours after delivery | 1.5 units on a scale | Standard Deviation 2.4 |
| Choice: Medium Protocol | Nausea Score Score at 24 and 48 After Delivery | 24-48 hours after delivery | 0.2 units on a scale | Standard Deviation 0.7 |
| Choice: High Protocol | Nausea Score Score at 24 and 48 After Delivery | 0-24 hours after delivery | 1.8 units on a scale | Standard Deviation 1.7 |
| Choice: High Protocol | Nausea Score Score at 24 and 48 After Delivery | 24-48 hours after delivery | 0.2 units on a scale | Standard Deviation 0.6 |
Patient Overall Satisfaction With Postoperative Analgesia
Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.
Time frame: 24 and 48 hours after delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Choice | Patient Overall Satisfaction With Postoperative Analgesia | 24 hours after delivery | 87.2 units on a scale | Standard Deviation 12.7 |
| No Choice | Patient Overall Satisfaction With Postoperative Analgesia | 48 hours after delivery | 89.9 units on a scale | Standard Deviation 10.6 |
| Choice: Low Protocol | Patient Overall Satisfaction With Postoperative Analgesia | 48 hours after delivery | 92.6 units on a scale | Standard Deviation 9.7 |
| Choice: Low Protocol | Patient Overall Satisfaction With Postoperative Analgesia | 24 hours after delivery | 90.3 units on a scale | Standard Deviation 10.4 |
| Choice: Medium Protocol | Patient Overall Satisfaction With Postoperative Analgesia | 24 hours after delivery | 94.1 units on a scale | Standard Deviation 9.5 |
| Choice: Medium Protocol | Patient Overall Satisfaction With Postoperative Analgesia | 48 hours after delivery | 91.2 units on a scale | Standard Deviation 15.1 |
| Choice: High Protocol | Patient Overall Satisfaction With Postoperative Analgesia | 24 hours after delivery | 93.3 units on a scale | Standard Deviation 7.7 |
| Choice: High Protocol | Patient Overall Satisfaction With Postoperative Analgesia | 48 hours after delivery | 89.3 units on a scale | Standard Deviation 14 |
Pruritus Score at 24 and 48 After Delivery
Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching.
Time frame: 24 and 48 hours following delivery
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Choice | Pruritus Score at 24 and 48 After Delivery | 48 hours after delivery | 0.8 units on a scale | Standard Deviation 1.3 |
| No Choice | Pruritus Score at 24 and 48 After Delivery | 24 hours after delivery | 4.2 units on a scale | Standard Deviation 2.7 |
| Choice: Low Protocol | Pruritus Score at 24 and 48 After Delivery | 24 hours after delivery | 1.7 units on a scale | Standard Deviation 2.3 |
| Choice: Low Protocol | Pruritus Score at 24 and 48 After Delivery | 48 hours after delivery | 0.2 units on a scale | Standard Deviation 0.6 |
| Choice: Medium Protocol | Pruritus Score at 24 and 48 After Delivery | 48 hours after delivery | 1.0 units on a scale | Standard Deviation 1.8 |
| Choice: Medium Protocol | Pruritus Score at 24 and 48 After Delivery | 24 hours after delivery | 3.7 units on a scale | Standard Deviation 2.5 |
| Choice: High Protocol | Pruritus Score at 24 and 48 After Delivery | 48 hours after delivery | 1.1 units on a scale | Standard Deviation 1.4 |
| Choice: High Protocol | Pruritus Score at 24 and 48 After Delivery | 24 hours after delivery | 4.5 units on a scale | Standard Deviation 2.7 |
Time to Discharge
Minutes from delivery until discharge.
Time frame: Delivery through discharge (average 4 days)
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Choice | Time to Discharge | 4771.9 minutes | Standard Deviation 1231.2 |
| Choice: Low Protocol | Time to Discharge | 4652.1 minutes | Standard Deviation 1006.7 |
| Choice: Medium Protocol | Time to Discharge | 5278.9 minutes | Standard Deviation 1410.3 |
| Choice: High Protocol | Time to Discharge | 5722.3 minutes | Standard Deviation 1391.9 |