Pain Management After Surgery

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05154682

Collaborator

(none)

200

Enrollment

Location

Arms

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 Disease	Intervention/Treatment	Phase
Pain, Postoperative	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

Arm	Intervention/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

Arm

Intervention/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

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

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

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:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2021