Clinical trial NCT02605187: Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
Official title: Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: cesarean
postoperative pain
patient choice
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Opioid Consumption in the 0-48 Hour Study Periods.
timeFrame: 0-24 and 24-48 hour postoperative periods
measure: Pain Scores
timeFrame: 3, 6, 12, 24, 36 and 48 hours after delivery
Secondary outcomes:
measure: Count of Participants Who Need Opioid Use
timeFrame: 0-24 and 24-48 hours after delivery
measure: Count of Participants With Presence of Pruritus
timeFrame: 0-24 and 24-48 hours after delivery
measure: Pruritus Score at 24 and 48 After Delivery
timeFrame: 24 and 48 hours following delivery
measure: Count of Participants Who Need Medical Treatment of Pruritus
timeFrame: 0-24 and 24-48 hours after delivery
measure: Counts of Participants With Presence of Nausea
timeFrame: 0-48 hours after delivery
measure: Nausea Score Score at 24 and 48 After Delivery
timeFrame: 0-24 and 24-48 hours after delivery
measure: Counts of Participants Who Need Medical Treatment for Nausea
timeFrame: 0-24 and 24-48 hours after delivery
measure: Average Number of Vomiting Episodes After Delivery
timeFrame: 0-24 and 24-48 hours after delivery
measure: Time to Discharge
timeFrame: Delivery through discharge (average 4 days)
measure: Patient Overall Satisfaction With Postoperative Analgesia
timeFrame: 24 and 48 hours after delivery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MBBCh, MDCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eisenach JC, Pan P, Smiley RM, Lavand'homme P, Landau R, Houle TT. Resolution of pain after childbirth. Anesthesiology. 2013 Jan;118(1):143-51. doi: 10.1097/ALN.0b013e318278ccfd.
citation: Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
citation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
citation: Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. doi: 10.1097/01.aco.0000245284.53152.1f.
citation: Carvalho B, Sutton CD, Kowalczyk JJ, Flood PD. Impact of patient choice for different postcesarean delivery analgesic protocols on opioid consumption: a randomized prospective clinical trial. Reg Anesth Pain Med. 2019 May;44(5):578-585. doi: 10.1136/rapm-2018-100206. Epub 2019 Mar 13.