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Dexamethasone for Pain Relief in Hand Surgery

Q: What is the upper limit in terms of participant numbers for this investigation?

Yes, the information on clinicaltrials.gov specifies that this medical trial is still open for recruitment and has been since October 23rd 2018. As of November 28th 2022, 108 participants are required from a single site.

Q: What conditions has Dexamethasone been found to ameliorate?

Dexamethasone is often utilized in the treatment of ophthalmia and sympathetic. Additionally, this pharmaceutical can be prescribed to alleviate eye-related issues such as branch retinal vein occlusion and macular edema.

Q: Has Dexamethasone ever been explored as a potential therapeutic in other investigative studies?

A search of active studies reveals 552 investigations into dexamethasone, with 143 at the third trial stage. The bulk of these trials are located in Mishawaka, <a href="https://www.withpower.com/clinical-trials/indiana">Indiana</a> yet there are also 18649 other sites running related research.

Q: Does this experimental program accept individuals aged fifty or above?

This experiment has an age cut-off of 18 years old and a maximum requirement of 80 to be eligible for enrolment.

Q: May I be included in the experiment?

This medical experiment is recruiting 108 patients between 18 and 80 years of age who are in need of an ORIF (open reduction internal fixation) or CMC (Carpometacarpal) arthroplasty. Eligible candidates must satisfy the following criteria: male/female, adult aged 18-80.

Q: Is enrollment for this study still available?

Indeed, the information hosted on clinicaltrials.gov reveals that this trial is currently looking to fill its ranks with 108 patients from a single site. This medical study was originally posted in October 2018 and most recently updated in November 2022.

Phase < 1

Recruiting

Led By Michael Kushelev, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing distal radius ORIF (open reduction internal fixation) or CMC (Carpometacarpal) arthroplasty

Have a valid phone number and be able to speak, read, and write in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

Study Summary

This trial will compare the duration of pain relief from ropivacaine when given with or without dexamethasone.

Who is the study for?

This trial is for adults aged 18-80 undergoing specific hand surgeries (distal radius ORIF or CMC arthroplasty) who can consent and communicate in English. Excluded are those with cognitive issues affecting pain perception, diabetes, severe lung disease, certain allergies, chronic pain history, a BMI ≥ 40 kg/m2, or are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests if dexamethasone given around the nerve and in the vein enhances ropivacaine's pain relief after hand surgery compared to ropivacaine alone or with IV dexamethasone only.See study design

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels (a concern for diabetics), immune system suppression leading to higher infection risk, mood swings, weight gain due to fluid retention, and insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery for a wrist fracture or thumb joint replacement.

Select...

I can speak, read, and write in English and have a valid phone number.

Select...

My health is good enough for surgery according to ASA standards.

Select...

I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of anesthetic blockade

Secondary outcome measures

48-hour postoperative units of oral morphine consumption

Duration of motor block

Patient satisfaction on a scale of 0-10 (0=not satisfied at all 10=very satisfied) of pain management

+2 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group B (IV + perineural dexamethasone)Experimental Treatment1 Intervention

(IV + perineural dexamethasone): Perineural (30ml of 0.75% ropivacaine + 0.5 ml of 10 mg/ml Dexamethasone) and IV (9.5 ml normal saline + 0.5 ml of 10 mg/ml Dexamethasone)

Group II: Group A (IV dexamethasone)Experimental Treatment1 Intervention

Perineural (30ml of 0.75% ropivacaine + 0.5 ml normal saline) and IV (9.0 ml normal saline + 1 ml of 10 mg/ml Dexamethasone)

Group III: Group C (control with no adjuvant dexamethasone)Active Control1 Intervention

Perineural (30ml of 0.75 ropivacaine + 0.5 ml normal saline) and IV (10 ml normal saline)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

828 Previous Clinical Trials

505,643 Total Patients Enrolled

Michael Kushelev, MDPrincipal InvestigatorAssistant Professor-Clinical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit in terms of participant numbers for this investigation?

"Yes, the information on clinicaltrials.gov specifies that this medical trial is still open for recruitment and has been since October 23rd 2018. As of November 28th 2022, 108 participants are required from a single site."

Answered by AI

What conditions has Dexamethasone been found to ameliorate?

"Dexamethasone is often utilized in the treatment of ophthalmia and sympathetic. Additionally, this pharmaceutical can be prescribed to alleviate eye-related issues such as branch retinal vein occlusion and macular edema."

Answered by AI

Has Dexamethasone ever been explored as a potential therapeutic in other investigative studies?

"A search of active studies reveals 552 investigations into dexamethasone, with 143 at the third trial stage. The bulk of these trials are located in Mishawaka, Indiana yet there are also 18649 other sites running related research."

Answered by AI

Does this experimental program accept individuals aged fifty or above?

"This experiment has an age cut-off of 18 years old and a maximum requirement of 80 to be eligible for enrolment."

Answered by AI

May I be included in the experiment?

"This medical experiment is recruiting 108 patients between 18 and 80 years of age who are in need of an ORIF (open reduction internal fixation) or CMC (Carpometacarpal) arthroplasty. Eligible candidates must satisfy the following criteria: male/female, adult aged 18-80."

Answered by AI

Is enrollment for this study still available?

"Indeed, the information hosted on clinicaltrials.gov reveals that this trial is currently looking to fill its ranks with 108 patients from a single site. This medical study was originally posted in October 2018 and most recently updated in November 2022."

Answered by AI