Caffeine Study for Pain Control Following Total Joint Replacement

NCT ID: NCT04280263

Last Updated: 2020-10-19

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

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2021-08-31

Brief Summary

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A prospective, double blinded, single center, randomized controlled study to evaluate the efficacy of caffeine in combination with acetyl salicylic acid (ASA) in the management of postoperative pain in patients undergoing total joint arthroplasty.

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

DOUBLE

Participants Outcome Assessors

Study Groups

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Caffiene

This group will receive 150mg caffeine tablets to be taken twice per day

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DRUG

caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day

placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day

Interventions

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Caffeine

caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day

Intervention Type DRUG

Placebo oral tablet

oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is older than 18 years old at the time of the surgery.
* Patient is treated by Rothman Orthopaedics institute and is scheduled for the surgical procedure at AtlantiCare Regional Medical Center.
* Patient is undergoing total hip or total knee arthroplasty.
* Patient has the diagnosis of Osteoarthritis of the hip or the knee, or other noninflammatory disease that results in joint damage to the hip or the knee.

Exclusion Criteria

* Patient has known history of opioid addiction and/or has taken opioids preoperatively.
* Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
* Patient has a known allergy to aspirin or caffeine.
* Patient has history of chronic pain that required the intervention of a pain management doctor.
* Patient has an active infection at the time of surgery (systemic or localized) or history of chronic infections that affected the lower extremities.
* Patient has history of cancer that would affect patient reported outcomes including pain.
* Patient has history of neuropathic pain or nerve degenerative disease.
* Patients undergoing revision surgery would be excluded.
* Patients who require alternate DTV prophylaxis other than ASA.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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2020 DP

Identifier Type: -

Identifier Source: org_study_id

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