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Opioid-sparing multimodal pain management for Postoperative Pain

N/A

Waitlist Available

Led By Silpa Nekkanti, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after the surgery on postoperative day 1 to 30

Awards & highlights

Study Summary

This trial is testing a new pain management protocol that includes ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery.

Eligible Conditions

Postoperative Pain
Cryotherapy Effect
Drug Abuse

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after the surgery on postoperative day 1 to 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after the surgery on postoperative day 1 to 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and after the surgery on postoperative day 1 to 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Day 1 pain score assessed by NRS-11

Secondary outcome measures

30-day postoperative outcomes

Adverse events (AEs)

Analgesic use - opioids measured by morphine equivalents

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Novel multimodal protocol groupExperimental Treatment1 Intervention

They will receive scheduled topical ice therapy for 24 hours after surgery. It will be applied over abdominal incisions for 20 minutes every 2-3 hours. Acetaminophen and an NSAID will be scheduled for 96 hours. While inpatient, they will receive acetaminophen 975 mg every 8 hours and IV Toradol 15-30 mg every 6 hours with change to ibuprofen 800 mg every 8 hours when tolerating oral intake. They may take oxycodone 5 mg every 4-6 hours as needed (PRN) for breakthrough pain and pain score >6. They may use ice PRN after 24 hours. They will be prescribed acetaminophen 1000 mg every 8 hours and ibuprofen 800 mg every 8 hours for 96 hours postoperative. They may take them as needed after. If the participant used 0 narcotics in the first 24 hours, they will not be prescribed a narcotic. If up to 5 tablets were used, they will be prescribed 5 tablets of oxycodone 5 mg every 6 hours PRN. If more than 5 tablets were used, they will be prescribed 10 tablets of oxycodone 5 mg every 6 hours PRN.

Group II: Usual care protocol groupActive Control1 Intervention

Participants randomly assigned to the usual care protocol will receive current standard of care: scheduled acetaminophen and an NSAID for 24 hours. They will take acetaminophen 975 mg every 8 hours. They will also receive IV toradol 15 to 30 mg every 6 hours then switch to ibuprofen 800 mg every 8 hours when tolerating oral intake. They can also take oxycodone 5 mg every 4 to 6 hours on an as needed (PRN) basis for breakthrough pain with a pain score >6. Per our current standard of care, usual care participants will be allowed to use either topical heat or ice on an as needed basis during their recovery. On discharge home, they will be prescribed acetaminophen 1000 mg every 8 hours PRN and ibuprofen 800 mg every 8 hours PRN. They will also be prescribed 15 tablets of oxycodone 5 mg every 6 hours PRN.

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Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,690 Total Patients Enrolled

1 Trials studying Postoperative Pain

108 Patients Enrolled for Postoperative Pain

Silpa Nekkanti, MDPrincipal InvestigatorOhio State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for new participants to join this research effort?

"Clinicaltrials.gov reports that enrollment for this trial is currently underway, having been announced on April 19th 2021 and updated most recently on April 20th 2022."

Answered by AI

How many individuals have been recruited for participation in this research?

"Affirmative. According to information found on clinicaltrials.gov, this medical trial is currently enrolling individuals as of April 20th 2022. The study was initiated in 2021 and requires 54 participants at a single location for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

Silpa Nekkanti 2021. "Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04710277.