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

Not Applicable

Completed

Conditions: Postoperative Pain

Interventions: Other: Choice given
Other: No choice given
Drug: Ibuprofen
Drug: Acetaminophen
Drug: Morphine (med)
Drug: Morphine (low)
Drug: Gabapentin
Drug: Morphine (high)

Registration Number: NCT02605187

Lead Sponsor: Stanford University

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 160

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No choice	Ibuprofen	No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice	Acetaminophen	No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: medium protocol	Morphine (med)	Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: low protocol	Ibuprofen	Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: low protocol	Choice given	Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: medium protocol	Acetaminophen	Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: high protocol	Ibuprofen	Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice: high protocol	Morphine (high)	Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
No choice	No choice given	No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice	Morphine (med)	No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: low protocol	Morphine (low)	Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: low protocol	Acetaminophen	Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: medium protocol	Choice given	Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: medium protocol	Ibuprofen	Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: high protocol	Choice given	Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice: high protocol	Gabapentin	Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice: high protocol	Acetaminophen	Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.