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

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ClinicalTrials.gov Identifier: NCT02605187

Recruitment Status : Completed

First Posted : November 16, 2015

Results First Posted : June 11, 2018

Last Update Posted : October 16, 2018

Sponsor:

Information provided by (Responsible Party):

Brendan Carvalho, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Other: No choice given Other: Choice given Drug: Ibuprofen Drug: Acetaminophen Drug: Gabapentin Drug: Morphine (low) Drug: Morphine (med) Drug: Morphine (high)	Not Applicable

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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:

Pain scores at rest and on to sitting (VPS 0-10) collected at 3, 6, 12, 24, 36, 48 hours post-cesarean
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.
Opioid use (oral and IV morphine) in the 0-24 and >24-48 hour study periods.
Time to first analgesic for breakthrough pain (minutes from spinal)
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
Any treatment of pruritus and/or nausea/vomiting
Satisfaction with postoperative analgesia score (0-100)
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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
Actual Study Start Date :	November 2015
Actual Primary Completion Date :	May 22, 2017
Actual Study Completion Date :	May 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Non-Drug Pain Management

U.S. FDA Resources

Arms and Interventions

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 Name: Medium dose morphine
Experimental: Choice: low protocol Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen 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: Ibuprofen Ibuprofen 600mg po q6h Drug: Acetaminophen Acetaminophen 650mg po q6h Drug: Morphine (low) Intrathecal morphine dose 50mcg Other Name: Low dose morphine
Experimental: Choice: medium protocol Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen 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: Ibuprofen Ibuprofen 600mg po q6h Drug: Acetaminophen Acetaminophen 650mg po q6h Drug: Morphine (med) Intrathecal morphine dose 150mcg Other Name: Medium dose morphine
Experimental: Choice: high protocol Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose	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: Ibuprofen Ibuprofen 600mg po q6h Drug: Acetaminophen Acetaminophen 650mg po q6h Drug: Gabapentin Gabapentin 600mg po one time within 1 hour of delivery Drug: Morphine (high) Intrathecal morphine 300mcg Other Name: High dose morphine

Outcome Measures

Primary Outcome Measures :

Opioid Consumption in the 0-48 Hour Study Periods. [ Time Frame: 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 [ Time Frame: 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 :

Count of Participants Who Need Opioid Use [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0-48 hours after delivery ]
Count of participants with nausea through 48 hours after delivery.
Nausea Score Score at 24 and 48 After Delivery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0-24 and 24-48 hours after delivery ]
Time to Discharge [ Time Frame: Delivery through discharge (average 4 days) ]
Minutes from delivery until discharge.
Patient Overall Satisfaction With Postoperative Analgesia [ Time Frame: 24 and 48 hours after delivery ]
Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605187

Locations

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

Sponsors and Collaborators

Stanford University

Investigators

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Principal Investigator:	Brendan Carvalho, MBBCh, MDCH	Stanford University

Study Documents (Full-Text)

Documents provided by Brendan Carvalho, Stanford University:

Study Protocol and Statistical Analysis Plan [PDF] October 26, 2015

More Information

Publications:

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.

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.

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review.

Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Brendan Carvalho, Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier:	NCT02605187
Other Study ID Numbers:	34740
First Posted:	November 16, 2015 Key Record Dates
Results First Posted:	June 11, 2018
Last Update Posted:	October 16, 2018
Last Verified:	September 2018

Keywords provided by Brendan Carvalho, Stanford University:


cesarean postoperative pain patient choice

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen Ibuprofen Morphine Gabapentin Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents	Peripheral Nervous System Agents Analgesics, Non-Narcotic Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents

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