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

Stanford University

Status: Completed

Conditions: Postoperative Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02605187

34740

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups

No choice

Active Comparator group

Description:

No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h

Treatment:

Drug: Morphine (med)

Other: No choice given

Drug: Acetaminophen

Drug: Ibuprofen

Choice: low protocol

Experimental group

Description:

Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Morphine (low)

Other: Choice given

Choice: medium protocol

Experimental group

Description:

Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h

Treatment:

Drug: Morphine (med)

Drug: Acetaminophen

Drug: Ibuprofen

Other: Choice given

Choice: high protocol

Experimental group

Description:

Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Gabapentin

Drug: Morphine (high)

Other: Choice given