Post-operative Pain ControlNCT03175653
Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control
A study testing Oxycodone Pill A and Oxycodone Pill B in people with Post-operative Pain Control, run by Mount Carmel Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-operative Pain Control
- What is being tested?
- Oxycodone Pill A and Oxycodone Pill B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial
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.
Read the 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
- Duration of use of narcotic after cesarean delivery, as assessed by the Post Cesarean Pain Control Survey (see attachment).
- Amount of narcotic unused after cesarean delivery, measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey.
- Disposition of unused drug, as assessed by the Post Cesarean Pain Control Survey.
- 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.
- Conditions
- Post-operative Pain Control
- Being tested
- Oxycodone Pill A, Oxycodone Pill B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone Pill AOther
Also called Oxycodone pill - lower number
Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.
Oxycodone Pill BOther
Also called Oxycodone pill - higher number
Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Oxycodone Pill A | Experimental | Participants in this study arm will receive a prescription for a lower number oxycodone (oxycodone A) pills for post-cesarean pain control. Receives: Other: Oxycodone Pill A |
| Arm B - Oxycodone Pill B | Active comparator | Participants in this study arm will receive a prescription for a higher number of oxycodone (oxycodone B) pills for post-cesarean pain control. Receives: Other: Oxycodone Pill B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery. .
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
Measured: 7-14 days after surgery
Secondary outcomes (4)
Duration of use of narcotic after cesarean
As assessed by the Post Cesarean Pain Control Survey
Measured: 7-14 days after surgery
Amount of narcotic unused after cesarean delivery.
Measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey
Measured: 7-14 days after surgery
Disposition of unused drug
As assessed by the Post Cesarean Pain Control Survey.
Measured: 7-14 days after surgery
Patient satisfaction with pain control after cesarean delivery
As assessed by the Post Cesarean Pain Control Survey.
Measured: 7-14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start16 Jun 2017
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Why it stopped: Feasibility - could not operationalize prior to PI leaving the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-operative Pain ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Prasad, DO, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175653
- Sponsor's protocol ID
- 170214-2
- Status last verified
- Sep 2020
- First submitted
- 4 May 2017
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reddy UM. Screening, Prevention, and Treatment of Opioid Use Disorder During Pregnancy: Expectant Mothers Are Depending on You! Obstet Gynecol. 2016 Jul;128(1):1-3. doi: 10.1097/AOG.0000000000001505. No abstract available.
PubMed 27275810Krans EE, Patrick SW. Opioid Use Disorder in Pregnancy: Health Policy and Practice in the Midst of an Epidemic. Obstet Gynecol. 2016 Jul;128(1):4-10. doi: 10.1097/AOG.0000000000001446.
PubMed 27275812Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2011. 2013 Oct. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #165. Available from http://www.ncbi.nlm.nih.gov/books/NBK174682/
PubMed 243540271. Osmundson, S, Grasch JL, Schornack LA, et al. Opioid Use after cesarean delivery following hospital discharge. American Journal of Obstetrics and Gynecology, 2017. 216:1(Supplement 1): Abstract 704, S411-S412.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03175653
- Acronym / sponsor ID
- 170214-2
- Conditions
- Post-operative Pain Control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility - could not operationalize prior to PI leaving the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Duration of use of narcotic after cesarean delivery, as assessed by the Post Cesarean Pain Control Survey (see attachment).
- Amount of narcotic unused after cesarean delivery, measured in number of remaining pills, as assessed by the Post Cesarean Pain Control Survey.
- Disposition of unused drug, as assessed by the Post Cesarean Pain Control Survey.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arm A - Oxycodone Pill A | Experimental | Other: Oxycodone Pill AParticipants in this study arm will receive a prescription for a lower number oxycodone (oxycodone A) pills for post-cesarean pain control. |
| Arm B - Oxycodone Pill B | Active comparator | Other: Oxycodone Pill BParticipants in this study arm will receive a prescription for a higher number of oxycodone (oxycodone B) pills for post-cesarean pain control. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone Pill AAlso: Oxycodone pill - lower numberPrescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid. | Other | Arm A - Oxycodone Pill A |
| Oxycodone Pill BAlso: Oxycodone pill - higher numberPrescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid. | Other | Arm B - Oxycodone Pill B |
Primary outcome
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
4 secondary outcomes
Duration of use of narcotic after cesarean
Time frame: 7-14 days after surgery
Amount of narcotic unused after cesarean delivery.
Time frame: 7-14 days after surgery
Disposition of unused drug
Time frame: 7-14 days after surgery
Patient satisfaction with pain control after cesarean delivery
Time frame: 7-14 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 27275810Reddy UM. Screening, Prevention, and Treatment of Opioid Use Disorder During Pregnancy: Expectant Mothers Are Depending on You! Obstet Gynecol. 2016 Jul;128(1):1-3. doi: 10.1097/AOG.0000000000001505. No abstract available.
- Background: PubMed 27275812Krans EE, Patrick SW. Opioid Use Disorder in Pregnancy: Health Policy and Practice in the Midst of an Epidemic. Obstet Gynecol. 2016 Jul;128(1):4-10. doi: 10.1097/AOG.0000000000001446.
- Background: PubMed 24354027Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2011. 2013 Oct. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #165. Available from http://www.ncbi.nlm.nih.gov/books/NBK174682/
- Background1. Osmundson, S, Grasch JL, Schornack LA, et al. Opioid Use after cesarean delivery following hospital discharge. American Journal of Obstetrics and Gynecology, 2017. 216:1(Supplement 1): Abstract 704, S411-S412.
- Individual participant dataSharing planned: No
Related trials for Post-operative Pain Control
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Prasad, DO principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone Pill A and Oxycodone Pill B in people with Post-operative Pain Control, run by Mount Carmel Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the percent of patients who refill their narcotic prescription after cesarean delivery. . (time frame: 7-14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175653, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.