Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Nov 2015
Typical duration for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2017
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedOctober 16, 2018
September 1, 2018
1.6 years
November 10, 2015
April 20, 2018
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Count of Participants Who Need Opioid Use
0-24 and 24-48 hours after delivery
Count of Participants With Presence of Pruritus
0-24 and 24-48 hours after delivery
Pruritus Score at 24 and 48 After Delivery
24 and 48 hours following delivery
Count of Participants Who Need Medical Treatment of Pruritus
0-24 and 24-48 hours after delivery
Counts of Participants With Presence of Nausea
0-48 hours after delivery
- +5 more secondary outcomes
Study Arms (4)
No choice
ACTIVE COMPARATORNo choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: low protocol
EXPERIMENTALChoice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: medium protocol
EXPERIMENTALChoice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice: high protocol
EXPERIMENTALChoice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Interventions
Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
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.
Ibuprofen 600mg po q6h
Acetaminophen 650mg po q6h
Intrathecal morphine dose 50mcg
Intrathecal morphine dose 150mcg
Intrathecal morphine 300mcg
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucille Packard Children's Hospital
Palo Alto, California, 94305, United States
Related Publications (5)
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.
PMID: 23249931BACKGROUNDEisenach 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.
PMID: 18818022BACKGROUNDKehlet 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.
PMID: 16698416BACKGROUNDLavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. doi: 10.1097/01.aco.0000245284.53152.1f.
PMID: 16960491BACKGROUNDCarvalho 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.
PMID: 30867278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Brendan Carvalho
- Organization
- Stanford University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Brendan Carvalho, MBBCh, MDCH
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 16, 2015
Study Start
November 1, 2015
Primary Completion
May 22, 2017
Study Completion
May 22, 2017
Last Updated
October 16, 2018
Results First Posted
June 11, 2018
Record last verified: 2018-09