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Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management

Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02605187
Enrollment
160
Registered
2015-11-16
Start date
2015-11-30
Completion date
2017-05-22
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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

OTHERNo 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.

OTHERChoice 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.

DRUGIbuprofen

Ibuprofen 600mg po q6h

DRUGAcetaminophen

Acetaminophen 650mg po q6h

DRUGGabapentin

Gabapentin 600mg po one time within 1 hour of delivery

DRUGMorphine (low)

Intrathecal morphine dose 50mcg

DRUGMorphine (med)

Intrathecal morphine dose 150mcg

DRUGMorphine (high)

Intrathecal morphine 300mcg

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Opioid Consumption in the 0-48 Hour Study Periods.0-24 and 24-48 hour postoperative periodsOpioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Pain Scores3, 6, 12, 24, 36 and 48 hours after deliveryPain 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

MeasureTime frameDescription
Pruritus Score at 24 and 48 After Delivery24 and 48 hours following deliveryScore 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 Pruritus0-24 and 24-48 hours after deliveryCount of participants who need medical treatment of pruritus during first 48 hours after delivery.
Counts of Participants With Presence of Nausea0-48 hours after deliveryCount of participants with nausea through 48 hours after delivery.
Nausea Score Score at 24 and 48 After Delivery0-24 and 24-48 hours after deliveryScore was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea.
Count of Participants Who Need Opioid Use0-24 and 24-48 hours after deliveryCount of participants who need opioid use through 48 hours after delivery.
Average Number of Vomiting Episodes After Delivery0-24 and 24-48 hours after delivery
Time to DischargeDelivery through discharge (average 4 days)Minutes from delivery until discharge.
Patient Overall Satisfaction With Postoperative Analgesia24 and 48 hours after deliveryScore 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 Nausea0-24 and 24-48 hours after deliveryCounts of participants who need medical treatment of nausea through 48 hours after delivery.
Count of Participants With Presence of Pruritus0-24 and 24-48 hours after deliveryCount of participants with pruritus through 48 hours after delivery.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total138

Baseline characteristics

CharacteristicNo ChoiceChoice: Low ProtocolChoice: Medium ProtocolChoice: High ProtocolTotal
Age, Continuous35 years37 years34 years33 years35 years
Body Mass Index (BMI)28 kg/m^228 kg/m^229 kg/m^230 kg/m^228 kg/m^2
Education
BA or equivalent
10 Participants3 Participants28 Participants6 Participants47 Participants
Education
Graduate Degree
13 Participants14 Participants33 Participants5 Participants65 Participants
Education
High school
4 Participants1 Participants3 Participants2 Participants10 Participants
Education
Some college
5 Participants1 Participants8 Participants2 Participants16 Participants
Gestational age (week)39.0 week39.1 week39.0 week39.0 week39.0 week
Language
English
27 Participants19 Participants66 Participants11 Participants123 Participants
Language
Other
5 Participants0 Participants6 Participants4 Participants15 Participants
Nulliparous4 Participants6 Participants16 Participants3 Participants29 Participants
Previous Cesarean Delivery21 Participants15 Participants45 Participants10 Participants91 Participants
Race/Ethnicity, Customized
Asian
9 Participants7 Participants27 Participants3 Participants46 Participants
Race/Ethnicity, Customized
Caucasian
19 Participants11 Participants42 Participants11 Participants83 Participants
Race/Ethnicity, Customized
Other
4 Participants1 Participants3 Participants1 Participants9 Participants
Sex: Female, Male
Female
32 Participants19 Participants72 Participants15 Participants138 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 190 / 720 / 15
other
Total, other adverse events
3 / 321 / 196 / 723 / 15
serious
Total, serious adverse events
0 / 320 / 190 / 720 / 15

Outcome results

Primary

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.

ArmMeasureGroupValue (MEDIAN)
No ChoiceOpioid Consumption in the 0-48 Hour Study Periods.24-48 hours10 milligram morphine equivalents (MMEQ)
No ChoiceOpioid Consumption in the 0-48 Hour Study Periods.0-24 hours10 milligram morphine equivalents (MMEQ)
Choice: Low ProtocolOpioid Consumption in the 0-48 Hour Study Periods.0-24 hours5 milligram morphine equivalents (MMEQ)
Choice: Low ProtocolOpioid Consumption in the 0-48 Hour Study Periods.24-48 hours0 milligram morphine equivalents (MMEQ)
Choice: Medium ProtocolOpioid Consumption in the 0-48 Hour Study Periods.24-48 hours5 milligram morphine equivalents (MMEQ)
Choice: Medium ProtocolOpioid Consumption in the 0-48 Hour Study Periods.0-24 hours10 milligram morphine equivalents (MMEQ)
Choice: High ProtocolOpioid Consumption in the 0-48 Hour Study Periods.24-48 hours30 milligram morphine equivalents (MMEQ)
Choice: High ProtocolOpioid Consumption in the 0-48 Hour Study Periods.0-24 hours5 milligram morphine equivalents (MMEQ)
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
No ChoicePain ScoresPain at rest tat 36 hours1.5 units on a scaleStandard Deviation 1.6
No ChoicePain ScoresPain at movement at 6 hours4.0 units on a scaleStandard Deviation 2.7
No ChoicePain ScoresPain at rest at 6 hours2.3 units on a scaleStandard Deviation 2.3
No ChoicePain ScoresPain at movement at 3 hours3.2 units on a scaleStandard Deviation 2.9
No ChoicePain ScoresPain at movement at 48 hours3.5 units on a scaleStandard Deviation 1.9
No ChoicePain ScoresPain at movement at 24 hours4.5 units on a scaleStandard Deviation 2.3
No ChoicePain ScoresPain at rest at 24 hours2.2 units on a scaleStandard Deviation 1.9
No ChoicePain ScoresPain at movement at 36 hours3.5 units on a scaleStandard Deviation 2.2
No ChoicePain ScoresPain at rest at 48 hours1.7 units on a scaleStandard Deviation 1.6
No ChoicePain ScoresPain at movement at 12 hours3.0 units on a scaleStandard Deviation 2.3
No ChoicePain ScoresPain at rest at 12 hours1.5 units on a scaleStandard Deviation 1.7
No ChoicePain ScoresPain at rest at 3 hours1.6 units on a scaleStandard Deviation 2
Choice: Low ProtocolPain ScoresPain at movement at 24 hours4.1 units on a scaleStandard Deviation 1.5
Choice: Low ProtocolPain ScoresPain at rest tat 36 hours1.7 units on a scaleStandard Deviation 1.3
Choice: Low ProtocolPain ScoresPain at movement at 36 hours4.0 units on a scaleStandard Deviation 2.1
Choice: Low ProtocolPain ScoresPain at rest at 3 hours1.8 units on a scaleStandard Deviation 2
Choice: Low ProtocolPain ScoresPain at movement at 3 hours3.4 units on a scaleStandard Deviation 2.5
Choice: Low ProtocolPain ScoresPain at rest at 6 hours2.7 units on a scaleStandard Deviation 1.9
Choice: Low ProtocolPain ScoresPain at movement at 6 hours4.4 units on a scaleStandard Deviation 2.4
Choice: Low ProtocolPain ScoresPain at rest at 12 hours2.1 units on a scaleStandard Deviation 1.7
Choice: Low ProtocolPain ScoresPain at movement at 12 hours4.7 units on a scaleStandard Deviation 1.5
Choice: Low ProtocolPain ScoresPain at rest at 24 hours1.9 units on a scaleStandard Deviation 1
Choice: Low ProtocolPain ScoresPain at rest at 48 hours2.0 units on a scaleStandard Deviation 1.9
Choice: Low ProtocolPain ScoresPain at movement at 48 hours3.9 units on a scaleStandard Deviation 1.8
Choice: Medium ProtocolPain ScoresPain at rest at 48 hours2.0 units on a scaleStandard Deviation 1.6
Choice: Medium ProtocolPain ScoresPain at movement at 6 hours3.8 units on a scaleStandard Deviation 2.4
Choice: Medium ProtocolPain ScoresPain at rest at 12 hours1.9 units on a scaleStandard Deviation 1.8
Choice: Medium ProtocolPain ScoresPain at movement at 36 hours4.5 units on a scaleStandard Deviation 2
Choice: Medium ProtocolPain ScoresPain at movement at 24 hours4.3 units on a scaleStandard Deviation 2
Choice: Medium ProtocolPain ScoresPain at movement at 12 hours3.6 units on a scaleStandard Deviation 2
Choice: Medium ProtocolPain ScoresPain at rest at 24 hours2.2 units on a scaleStandard Deviation 1.7
Choice: Medium ProtocolPain ScoresPain at rest tat 36 hours2.6 units on a scaleStandard Deviation 2
Choice: Medium ProtocolPain ScoresPain at movement at 3 hours3.2 units on a scaleStandard Deviation 2.7
Choice: Medium ProtocolPain ScoresPain at movement at 48 hours3.6 units on a scaleStandard Deviation 1.8
Choice: Medium ProtocolPain ScoresPain at rest at 6 hours2.2 units on a scaleStandard Deviation 1.8
Choice: Medium ProtocolPain ScoresPain at rest at 3 hours1.9 units on a scaleStandard Deviation 2.1
Choice: High ProtocolPain ScoresPain at movement at 48 hours4.8 units on a scaleStandard Deviation 2.5
Choice: High ProtocolPain ScoresPain at movement at 3 hours4.1 units on a scaleStandard Deviation 2.5
Choice: High ProtocolPain ScoresPain at movement at 6 hours3.8 units on a scaleStandard Deviation 2.4
Choice: High ProtocolPain ScoresPain at movement at 36 hours4.8 units on a scaleStandard Deviation 1.8
Choice: High ProtocolPain ScoresPain at rest at 48 hours3.3 units on a scaleStandard Deviation 2.2
Choice: High ProtocolPain ScoresPain at rest at 24 hours2.3 units on a scaleStandard Deviation 1.7
Choice: High ProtocolPain ScoresPain at rest at 12 hours1.7 units on a scaleStandard Deviation 1.7
Choice: High ProtocolPain ScoresPain at rest at 3 hours2.2 units on a scaleStandard Deviation 2.2
Choice: High ProtocolPain ScoresPain at movement at 24 hours3.6 units on a scaleStandard Deviation 1.8
Choice: High ProtocolPain ScoresPain at rest at 6 hours1.5 units on a scaleStandard Deviation 1.6
Choice: High ProtocolPain ScoresPain at movement at 12 hours3.2 units on a scaleStandard Deviation 2.1
Choice: High ProtocolPain ScoresPain at rest tat 36 hours3.1 units on a scaleStandard Deviation 2.4
Comparison: Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.p-value: 0.882ANOVA
Comparison: Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.p-value: 0.565ANOVA
Comparison: Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.p-value: 0.022ANOVA
Comparison: Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.p-value: 0.14ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
No ChoiceAverage Number of Vomiting Episodes After Delivery24-48 hours after delivery0 vomiting episodesStandard Deviation 0
No ChoiceAverage Number of Vomiting Episodes After Delivery0-24 hours after delivery0.6 vomiting episodesStandard Deviation 1.5
Choice: Low ProtocolAverage Number of Vomiting Episodes After Delivery0-24 hours after delivery0.3 vomiting episodesStandard Deviation 1
Choice: Low ProtocolAverage Number of Vomiting Episodes After Delivery24-48 hours after delivery0 vomiting episodesStandard Deviation 0
Choice: Medium ProtocolAverage Number of Vomiting Episodes After Delivery0-24 hours after delivery0.5 vomiting episodesStandard Deviation 1.4
Choice: Medium ProtocolAverage Number of Vomiting Episodes After Delivery24-48 hours after delivery0 vomiting episodesStandard Deviation 0
Choice: High ProtocolAverage Number of Vomiting Episodes After Delivery24-48 hours after delivery0 vomiting episodesStandard Deviation 0
Choice: High ProtocolAverage Number of Vomiting Episodes After Delivery0-24 hours after delivery1.3 vomiting episodesStandard Deviation 2
Comparison: Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equalp-value: 0.226ANOVA
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No ChoiceCount of Participants Who Need Medical Treatment of Pruritus0-24 hours after delivery7 Participants
No ChoiceCount of Participants Who Need Medical Treatment of Pruritus24-48 hours after delivery2 Participants
Choice: Low ProtocolCount of Participants Who Need Medical Treatment of Pruritus24-48 hours after delivery0 Participants
Choice: Low ProtocolCount of Participants Who Need Medical Treatment of Pruritus0-24 hours after delivery2 Participants
Choice: Medium ProtocolCount of Participants Who Need Medical Treatment of Pruritus0-24 hours after delivery12 Participants
Choice: Medium ProtocolCount of Participants Who Need Medical Treatment of Pruritus24-48 hours after delivery2 Participants
Choice: High ProtocolCount of Participants Who Need Medical Treatment of Pruritus0-24 hours after delivery3 Participants
Choice: High ProtocolCount of Participants Who Need Medical Treatment of Pruritus24-48 hours after delivery0 Participants
Comparison: Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.p-value: 0.759Fisher Exact
Comparison: Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.p-value: 0.761Fisher Exact
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No ChoiceCount of Participants Who Need Opioid Use0-24 hours after delivery27 Participants
No ChoiceCount of Participants Who Need Opioid Use24-48 hours after delivery23 Participants
Choice: Low ProtocolCount of Participants Who Need Opioid Use24-48 hours after delivery8 Participants
Choice: Low ProtocolCount of Participants Who Need Opioid Use0-24 hours after delivery14 Participants
Choice: Medium ProtocolCount of Participants Who Need Opioid Use0-24 hours after delivery50 Participants
Choice: Medium ProtocolCount of Participants Who Need Opioid Use24-48 hours after delivery42 Participants
Choice: High ProtocolCount of Participants Who Need Opioid Use0-24 hours after delivery13 Participants
Choice: High ProtocolCount of Participants Who Need Opioid Use24-48 hours after delivery14 Participants
Comparison: Comparison of opioid use 0-24 hours after delivery.p-value: 0.311Fisher Exact
Comparison: Comparison of opioid use 24-48 hours after delivery.p-value: 0.008Fisher Exact
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No ChoiceCount of Participants With Presence of Pruritus0-24 hours after delivery27 Participants
No ChoiceCount of Participants With Presence of Pruritus24-48 hours after delivery12 Participants
Choice: Low ProtocolCount of Participants With Presence of Pruritus24-48 hours after delivery3 Participants
Choice: Low ProtocolCount of Participants With Presence of Pruritus0-24 hours after delivery11 Participants
Choice: Medium ProtocolCount of Participants With Presence of Pruritus0-24 hours after delivery63 Participants
Choice: Medium ProtocolCount of Participants With Presence of Pruritus24-48 hours after delivery29 Participants
Choice: High ProtocolCount of Participants With Presence of Pruritus0-24 hours after delivery13 Participants
Choice: High ProtocolCount of Participants With Presence of Pruritus24-48 hours after delivery7 Participants
Comparison: Comparison of presence of pruritus 0-24 hours after delivery.p-value: 0.092Fisher Exact
Comparison: Comparison of presence of pruritus 24-48 hours after delivery.p-value: 0.269Fisher Exact
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No ChoiceCounts of Participants Who Need Medical Treatment for Nausea0-24 hours after delivery8 Participants
No ChoiceCounts of Participants Who Need Medical Treatment for Nausea24-48 hours after delivery0 Participants
Choice: Low ProtocolCounts of Participants Who Need Medical Treatment for Nausea24-48 hours after delivery1 Participants
Choice: Low ProtocolCounts of Participants Who Need Medical Treatment for Nausea0-24 hours after delivery9 Participants
Choice: Medium ProtocolCounts of Participants Who Need Medical Treatment for Nausea0-24 hours after delivery20 Participants
Choice: Medium ProtocolCounts of Participants Who Need Medical Treatment for Nausea24-48 hours after delivery0 Participants
Choice: High ProtocolCounts of Participants Who Need Medical Treatment for Nausea0-24 hours after delivery9 Participants
Choice: High ProtocolCounts of Participants Who Need Medical Treatment for Nausea24-48 hours after delivery0 Participants
Comparison: Comparison of participants who need nausea treatment from 0-24 hours after delivery.p-value: 0.057Chi-squared
Comparison: Comparison of participants who need nausea treatment from 24-48 hours after delivery.p-value: 0.246Fisher Exact
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No ChoiceCounts of Participants With Presence of Nausea11 Participants
Choice: Low ProtocolCounts of Participants With Presence of Nausea7 Participants
Choice: Medium ProtocolCounts of Participants With Presence of Nausea33 Participants
Choice: High ProtocolCounts of Participants With Presence of Nausea10 Participants
p-value: 0.281Chi-squared
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
No ChoiceNausea Score Score at 24 and 48 After Delivery0-24 hours after delivery1.3 units on a scaleStandard Deviation 2.4
No ChoiceNausea Score Score at 24 and 48 After Delivery24-48 hours after delivery0.3 units on a scaleStandard Deviation 0.9
Choice: Low ProtocolNausea Score Score at 24 and 48 After Delivery24-48 hours after delivery0.2 units on a scaleStandard Deviation 0.5
Choice: Low ProtocolNausea Score Score at 24 and 48 After Delivery0-24 hours after delivery1.1 units on a scaleStandard Deviation 2
Choice: Medium ProtocolNausea Score Score at 24 and 48 After Delivery0-24 hours after delivery1.5 units on a scaleStandard Deviation 2.4
Choice: Medium ProtocolNausea Score Score at 24 and 48 After Delivery24-48 hours after delivery0.2 units on a scaleStandard Deviation 0.7
Choice: High ProtocolNausea Score Score at 24 and 48 After Delivery0-24 hours after delivery1.8 units on a scaleStandard Deviation 1.7
Choice: High ProtocolNausea Score Score at 24 and 48 After Delivery24-48 hours after delivery0.2 units on a scaleStandard Deviation 0.6
Comparison: Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equalp-value: 0.786ANOVA
Comparison: Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equalp-value: 0.985ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
No ChoicePatient Overall Satisfaction With Postoperative Analgesia24 hours after delivery87.2 units on a scaleStandard Deviation 12.7
No ChoicePatient Overall Satisfaction With Postoperative Analgesia48 hours after delivery89.9 units on a scaleStandard Deviation 10.6
Choice: Low ProtocolPatient Overall Satisfaction With Postoperative Analgesia48 hours after delivery92.6 units on a scaleStandard Deviation 9.7
Choice: Low ProtocolPatient Overall Satisfaction With Postoperative Analgesia24 hours after delivery90.3 units on a scaleStandard Deviation 10.4
Choice: Medium ProtocolPatient Overall Satisfaction With Postoperative Analgesia24 hours after delivery94.1 units on a scaleStandard Deviation 9.5
Choice: Medium ProtocolPatient Overall Satisfaction With Postoperative Analgesia48 hours after delivery91.2 units on a scaleStandard Deviation 15.1
Choice: High ProtocolPatient Overall Satisfaction With Postoperative Analgesia24 hours after delivery93.3 units on a scaleStandard Deviation 7.7
Choice: High ProtocolPatient Overall Satisfaction With Postoperative Analgesia48 hours after delivery89.3 units on a scaleStandard Deviation 14
Comparison: Comparison of satisfaction with pain medication 24 hours after delivery.p-value: 0.019ANOVA
Comparison: Comparison of satisfaction with pain medication 48 hours after delivery.p-value: 0.873ANOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
No ChoicePruritus Score at 24 and 48 After Delivery48 hours after delivery0.8 units on a scaleStandard Deviation 1.3
No ChoicePruritus Score at 24 and 48 After Delivery24 hours after delivery4.2 units on a scaleStandard Deviation 2.7
Choice: Low ProtocolPruritus Score at 24 and 48 After Delivery24 hours after delivery1.7 units on a scaleStandard Deviation 2.3
Choice: Low ProtocolPruritus Score at 24 and 48 After Delivery48 hours after delivery0.2 units on a scaleStandard Deviation 0.6
Choice: Medium ProtocolPruritus Score at 24 and 48 After Delivery48 hours after delivery1.0 units on a scaleStandard Deviation 1.8
Choice: Medium ProtocolPruritus Score at 24 and 48 After Delivery24 hours after delivery3.7 units on a scaleStandard Deviation 2.5
Choice: High ProtocolPruritus Score at 24 and 48 After Delivery48 hours after delivery1.1 units on a scaleStandard Deviation 1.4
Choice: High ProtocolPruritus Score at 24 and 48 After Delivery24 hours after delivery4.5 units on a scaleStandard Deviation 2.7
Comparison: Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equalp-value: 0.006ANOVA
Comparison: Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equalp-value: 0.296ANOVA
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
No ChoiceTime to Discharge4771.9 minutesStandard Deviation 1231.2
Choice: Low ProtocolTime to Discharge4652.1 minutesStandard Deviation 1006.7
Choice: Medium ProtocolTime to Discharge5278.9 minutesStandard Deviation 1410.3
Choice: High ProtocolTime to Discharge5722.3 minutesStandard Deviation 1391.9
p-value: 0.036ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026