MedDataX Logo

Pain Management After Surgery

NCT ID: NCT05154682

Last Updated: 2021-12-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AILY 21D.615

Identifier Type: -

Identifier Source: org_study_id