Pain Management After Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxycodone Group (Control Group)

Patients will receive oxycodone as needed after surgery

Group Type ACTIVE_COMPARATOR

OxyCODONE 5 mg Oral Tablet

Intervention Type DRUG

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

Oxycodone+ Naproxen/Acetaminophen (Study Group)

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

Group Type ACTIVE_COMPARATOR

OxyCODONE 5 mg Oral Tablet

Intervention Type DRUG

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

Acetaminophen 500Mg Tab

Intervention Type DRUG

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

Naproxen 500 Mg

Intervention Type DRUG

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

Interventions

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OxyCODONE 5 mg Oral Tablet

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

Intervention Type DRUG

Acetaminophen 500Mg Tab

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

Intervention Type DRUG

Naproxen 500 Mg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes