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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605187
• Other study ID #: 34740
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 22, 2017

Study information

• Verified date: September 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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
• Acetaminophen
Acetaminophen 650mg po q6h
• Gabapentin
Gabapentin 600mg po one time within 1 hour of delivery
• Morphine (low)
Intrathecal morphine dose 50mcg
• Morphine (med)
Intrathecal morphine dose 150mcg
• Morphine (high)
Intrathecal morphine 300mcg

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Counts of Participants With Presence of Nausea	Count of participants with nausea through 48 hours after delivery.	0-48 hours after delivery
Secondary	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
Secondary	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
Secondary	Average Number of Vomiting Episodes After Delivery		0-24 and 24-48 hours after delivery
Secondary	Time to Discharge	Minutes from delivery until discharge.	Delivery through discharge (average 4 days)
Secondary	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