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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: No choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (med); Other: Choice given; Drug: Morphine (low); Drug: Gabapentin; Drug: Morphine (high)

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Lucille Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No choice; No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h	Other: 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.; Drug: Ibuprofen; Ibuprofen 600mg po q6h; Drug: Acetaminophen; Acetaminophen 650mg po q6h; Drug: Morphine (med); Intrathecal morphine dose 150mcg; Other Names: Medium dose morphine
Experimental: Choice: low protocol; Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h	Drug: Ibuprofen; Ibuprofen 600mg po q6h; Drug: Acetaminophen; Acetaminophen 650mg po q6h; Other: 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.; Drug: Morphine (low); Intrathecal morphine dose 50mcg; Other Names: Low dose morphine
Experimental: Choice: medium protocol; Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h	Drug: Ibuprofen; Ibuprofen 600mg po q6h; Drug: Acetaminophen; Acetaminophen 650mg po q6h; Drug: Morphine (med); Intrathecal morphine dose 150mcg; Other Names: Medium dose morphine; Other: 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.
Experimental: Choice: high protocol; Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose	Drug: Ibuprofen; Ibuprofen 600mg po q6h; Drug: Acetaminophen; Acetaminophen 650mg po q6h; Other: 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.; Drug: Gabapentin; Gabapentin 600mg po one time within 1 hour of delivery; Drug: Morphine (high); Intrathecal morphine 300mcg; Other Names: High dose morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-24 and 24-48 hour postoperative periods
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.	3, 6, 12, 24, 36 and 48 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants Who Need Opioid Use	Count of participants who need opioid use through 48 hours after delivery.	0-24 and 24-48 hours after delivery
Count of Participants With Presence of Pruritus	Count of participants with pruritus through 48 hours after delivery.	0-24 and 24-48 hours after delivery
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.	24 and 48 hours following delivery
Count of Participants Who Need Medical Treatment of Pruritus	Count of participants who need medical treatment of pruritus during first 48 hours after delivery.	0-24 and 24-48 hours after delivery
Counts of Participants With Presence of Nausea	Count of participants with nausea through 48 hours after delivery.	0-48 hours after delivery
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.	0-24 and 24-48 hours after delivery
Counts of Participants Who Need Medical Treatment for Nausea	Counts of participants who need medical treatment of nausea through 48 hours after delivery.	0-24 and 24-48 hours after delivery
Average Number of Vomiting Episodes After Delivery		0-24 and 24-48 hours after delivery
Time to Discharge	Minutes from delivery until discharge.	Delivery through discharge (average 4 days)
Patient Overall Satisfaction With Postoperative Analgesia	Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.	24 and 48 hours after delivery

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. doi: 10.1097/01.aco.0000245284.53152.1f.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): May 22, 2017
• Study Completion (Actual): May 22, 2017

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: postoperative pain; cesarean; patient choice
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin; Acetaminophen; Morphine; Ibuprofen
• Other Study ID Numbers: 34740