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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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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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


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




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Counts of Participants With Presence of Nausea [ Time Frame: 0-48 hours after delivery ]
    Count of participants with nausea through 48 hours after delivery.

  6. 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.

  7. 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.

  8. Average Number of Vomiting Episodes After Delivery [ Time Frame: 0-24 and 24-48 hours after delivery ]
  9. Time to Discharge [ Time Frame: Delivery through discharge (average 4 days) ]
    Minutes from delivery until discharge.

  10. 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.



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)

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