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Preoperative Nerve Block for Shoulder Surgery Anesthesia

Phase 2 & 3

Recruiting

Led By Timur JP Özelsel, MD, DESA

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Patients undergoing elective shoulder arthroscopy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 postoperative hours

Awards & highlights

Study Summary

This trial is investigating whether or not freezing the nerves before surgery can reduce the amount of anesthetic used, and therefore the environmental footprint, for shoulder surgery patients.

Who is the study for?

Adults over 18 who can consent and are having elective shoulder surgery with eligibility for a nerve block. Excluded are those with blood clotting issues, inability to consent, severe other illnesses, allergies to local anesthetics, obesity (BMI >35), or pre-existing nerve problems.Check my eligibility

What is being tested?

The study is testing if using a nerve block before shoulder replacement surgery reduces the amount of inhaled anesthetic needed during the operation. This could lessen post-surgery opioid use and hospital stay costs while also reducing environmental impact.See study design

What are the potential side effects?

Possible side effects include discomfort from the nerve block procedure itself and potential risks associated with anesthesia such as nausea or respiratory complications. The specific side effects of Dextrose and Ropivacaine may include numbness and weakness in the area.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for a shoulder surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative period

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

Treatment Details

Study Objectives

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

Primary outcome measures

Average age-adjusted MAC of sevoflurane

Secondary outcome measures

24 hour opioid consumption

Intraoperative heart rate

Intraoperative mean blood pressure

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PRE-GAActive Control2 Interventions

10 mL of 1% ropivacaine injection before the start of surgery and 10 ml of 5% dextrose injection at the end of surgery through the interscalene catheter

Group II: POST-GAPlacebo Group2 Interventions

10 ml of 5% dextrose injection before the start of surgery and 1% ropivacaine injection at the end of surgery through the interscalene catheter

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,084 Total Patients Enrolled

3 Trials studying Rotator Cuff Tears

523 Patients Enrolled for Rotator Cuff Tears

Vivian HY Ip, MDStudy DirectorUniversity of Alberta

3 Previous Clinical Trials

127 Total Patients Enrolled

Lora Pencheva, MDStudy DirectorUniversity of Alberta

2 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

PRE-GA Clinical Trial Eligibility Overview. Trial Name: NCT04020601 — Phase 2 & 3

Rotator Cuff Tears Research Study Groups: POST-GA, PRE-GA

Rotator Cuff Tears Clinical Trial 2023: PRE-GA Highlights & Side Effects. Trial Name: NCT04020601 — Phase 2 & 3

PRE-GA 2023 Treatment Timeline for Medical Study. Trial Name: NCT04020601 — Phase 2 & 3

Frequently Asked Questions

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

Has this particular experiment been conducted before?

"PRE-GA has been researched since 2007 and first received clinical trials in the same year, courtesy of Baxter Healthcare Corporation. Out of the 4640 patients that were initially involved in the study, Phase 4 drug approval was given to PRE-GA. As of now, there are 80 active trials for PRE-GA in 175 different cities and 37 countries."

Answered by AI

For what reason is PRE-GA often recommended?

"PRE-GA can help with labour, the collection of blood specimens, and caloric deficits."

Answered by AI

Does PRE-GA have a history of being investigated in clinical trials?

"There are currently 80 clinical trials involving PRE-GA with 18 of those in the third phase. The majority of these PRE-GA trials are based in Chicago, but there are 307 total sites running these trials."

Answered by AI

Is this experiment still recruiting patients who wish to participate?

"That is correct, the listing on clinicaltrials.gov indicates that the research team is currently recruiting patients. The study was first advertised on August 1st, 2019 and was most recently updated on May 23rd, 2022. They are looking for 50 individuals total, across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty

2019. "The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04020601.