Pain Management After Surgery

Sponsor
Rothman Institute Orthopaedics (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05154682
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: OxyCODONE 5 mg Oral Tablet
  • Drug: Acetaminophen 500Mg Tab
  • Drug: Naproxen 500 Mg
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Oxycodone Group (Control Group)

Patients will receive oxycodone as needed after surgery

Drug: OxyCODONE 5 mg Oral Tablet
Oxycodone will be given every 4 hours as needed for 2 weeks after surgery

Active Comparator: Oxycodone+ Naproxen/Acetaminophen (Study Group)

each patient will receive oxycodone plus acetaminophen and naproxen for 2 weeks after surgery

Drug: OxyCODONE 5 mg Oral Tablet
Oxycodone will be given every 4 hours as needed for 2 weeks after surgery

Drug: Acetaminophen 500Mg Tab
Acetaminophen will be taken every 4 hours for 2 weeks after surgery

Drug: Naproxen 500 Mg
Naproxen will be taken every 12 hours for 2 weeks after surgery

Outcome Measures

Primary Outcome Measures

  1. Postoperative Pain [14 days]

    With the use of an 11 point numeric rating scale (NRS) daily satisfaction with their pain regimen, patients pain level and medication usage will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age ≥ 18 years old

  • undergoing elective outpatient orthopaedic surgery under general anesthesia.

Exclusion Criteria:
  • Age < 18 years old

  • Non-English speaking

  • allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).

  • currently taking opioid medications

  • history of chronic opioid therapy for chronic pain

  • surgery being performed under local anesthesia only, without general anesthesia or sedation

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Rothman Orthopaedic InstitutePhiladelphiaPennsylvaniaUnited States19107

Sponsors and Collaborators

  • Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT05154682
Other Study ID Numbers:
  • AILY 21D.615
First Posted:
Dec 13, 2021
Last Update Posted:
Dec 13, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2021