Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03175653
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mona Prasad, Mount Carmel Health System

Brief Summary:

The purpose of this randomized trial is to examine whether the number of opioid pills prescribed for pain control after Cesarean section has an effect on patient reported pain levels and satisfaction with pain control during recovery. Both groups receive what is considered an adequate number of pills for pain control after an uncomplicated Cesarean delivery. Secondarily, the investigators wish to gather reliable information about the duration of use of opioids for pain control after uncomplicated Cesarean section, and what happens to unused medication.

After an uncomplicated Cesarean section, patients will be approached and asked to participate in the study. If the patient agrees, she will be randomly assigned to one of the two study groups and receive a prescription for opioid medication at the time of hospital discharge. At her standard care follow-up visit 10-14 days later, the participant will complete a survey asking questions about her pain levels during recovery, her use of study-related and non-study-related pain medication, and satisfaction with pain control. At that point the patient's participation in the study will end.


Condition or disease Intervention/treatment Phase
Post-operative Pain Control Other: Oxycodone Pill A Other: Oxycodone Pill B Not Applicable

Detailed Description:

Study Design and Methods:

The investigators will conduct a randomized controlled trial evaluating the difference in postpartum pain control in women receiving two different amounts of oxycodone after cesarean delivery.

Primary outcomes

• The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery.

Secondary outcomes

  1. Duration of use of narcotic after cesarean delivery, as assessed by the Post Cesarean Pain Control Survey (see attachment).
  2. Amount of narcotic unused after cesarean delivery, measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey.
  3. Disposition of unused drug, as assessed by the Post Cesarean Pain Control Survey.
  4. Patient satisfaction with pain control after cesarean delivery, as assessed by the Post Cesarean Pain Control Survey.

Patients will be identified by one of the investigators or designated research staff as either scheduled to undergo repeat cesarean delivery or status post cesarean from review of postpartum delivery lists. If they meet inclusion and exclusion criteria, they will be approached for enrollment in the study. If they consent they will be randomized on the day of discharge to group A or group B via sequentially numbered, sealed, opaque envelope. All patients will be provided standard education regarding pain control in the form of a fact sheet regarding trajectories of pain resolution, normative opioid consumption post cesarean, as well as risks, benefits and alternatives to opiates. If unable to purchase over the counter medications, prescriptions for ibuprofen and acetaminophen will be provided, as well as phone numbers for contact should any concerns arise between the time of discharge and post operative assessment. The patient will be scheduled for a postoperative wound check 10-14 days postpartum.

Postoperative wound evaluation will be performed in the research site's OB clinic setting at which time the survey will be completed by the patient regarding satisfaction with pain control, length of opiate treatment, number of opiates left in prescription and need for refills.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Masking Description: Participants and investigators will be aware of the arm to which they have been assigned.
Primary Purpose: Other
Official Title: Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A - Oxycodone Pill A
Participants in this study arm will receive a prescription for a lower number oxycodone (oxycodone A) pills for post-cesarean pain control.
Other: Oxycodone Pill A
Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.
Other Name: Oxycodone pill - lower number

Active Comparator: Arm B - Oxycodone Pill B
Participants in this study arm will receive a prescription for a higher number of oxycodone (oxycodone B) pills for post-cesarean pain control.
Other: Oxycodone Pill B
Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.
Other Name: Oxycodone pill - higher number




Primary Outcome Measures :
  1. The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery. . [ Time Frame: 7-14 days after surgery ]
    This outcome will be assessed by survey and confirmed with Ohio Automatic Rx Reporting System (OARRS) review performed on the same day as survey completion


Secondary Outcome Measures :
  1. Duration of use of narcotic after cesarean [ Time Frame: 7-14 days after surgery ]
    As assessed by the Post Cesarean Pain Control Survey

  2. Amount of narcotic unused after cesarean delivery. [ Time Frame: 7-14 days after surgery ]
    Measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey

  3. Disposition of unused drug [ Time Frame: 7-14 days after surgery ]
    As assessed by the Post Cesarean Pain Control Survey.

  4. Patient satisfaction with pain control after cesarean delivery [ Time Frame: 7-14 days after surgery ]
    As assessed by the Post Cesarean Pain Control Survey.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females who self-identify, are able to get pregnant and who undergo Cesarean section.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18-45 years
  • English, Somali or Spanish Speaking
  • Status post uncomplicated cesarean delivery performed at term (37w 0d to 42w 0d at time of delivery)
  • Discharged at day 3 or 4 after cesarean section
  • Willingness to participate in a survey 10-14 days post cesarean

Exclusion Criteria:

  • History of or current narcotic abuse
  • History of chronic pain
  • History or current opiate addiction
  • Complicated cesarean delivery including cesarean hysterectomy, EBL >1500 cc, bowel or bladder injury, postpartum infectious morbidity, postpartum wound break down
  • Neonatal outcome requiring NICU admission for more than 48 hours

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): NCT03175653


Contacts
Layout table for location contacts
Contact: Mona Prasad, DO 614-293-3773 Mona.Prasad@osumc.edu
Contact: Lynn Shaffer, PhD 614-234-3625 Lynn.Shaffer@mchs.com

Locations
Layout table for location information
United States, Ohio
Mt Carmel Medical Center Recruiting
Columbus, Ohio, United States, 43222
Contact: Lynn Shaffer, PhD    614-234-3625    lynn.shaffer@mchs.com   
Contact: Mona Prasad, DO MPH    6142341251    mona.prasad@osumc.edu   
Principal Investigator: Mona Prasad, DO MPH         
Sponsors and Collaborators
Mount Carmel Health System
Investigators
Layout table for investigator information
Principal Investigator: Mona Prasad, DO Mount Carmel Health System

Publications:
Layout table for additonal information
Responsible Party: Mona Prasad, Principal Investigator, Mount Carmel Health System
ClinicalTrials.gov Identifier: NCT03175653     History of Changes
Other Study ID Numbers: 170214-2
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents