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Pain Management After Surgery

Primary Purpose

Pain, Postoperative

Status

Enrolling by invitation

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

OxyCODONE 5 mg Oral Tablet

Acetaminophen 500Mg Tab

Naproxen 500 Mg

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oxycodone Group (Control Group)

Oxycodone+ Naproxen/Acetaminophen (Study Group)

Arm Description

Patients will receive oxycodone as needed after surgery

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

Outcomes

Primary Outcome Measures

Postoperative Pain

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05154682

First Posted

November 30, 2021

Last Updated

November 30, 2021

Sponsor

Rothman Institute Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT05154682

Brief Title

Pain Management After Surgery

Official Title

Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Enrolling by invitation

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

November 30, 2022 (Anticipated)

Study Completion Date

November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxycodone Group (Control Group)

Arm Type

Active Comparator

Arm Description

Patients will receive oxycodone as needed after surgery

Arm Title

Oxycodone+ Naproxen/Acetaminophen (Study Group)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

OxyCODONE 5 mg Oral Tablet

Intervention Description

Oxycodone will be given every 4 hours as needed for 2 weeks after surgery

Intervention Type

Drug

Intervention Name(s)

Acetaminophen 500Mg Tab

Intervention Description

Acetaminophen will be taken every 4 hours for 2 weeks after surgery

Intervention Type

Drug

Intervention Name(s)

Naproxen 500 Mg

Intervention Description

Naproxen will be taken every 12 hours for 2 weeks after surgery

Primary Outcome Measure Information:

Title

Postoperative Pain

Description

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.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rothman Orthopaedic Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pain Management After Surgery

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