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Local Anesthesia

iPACK Block for Postoperative Pain in Knee Surgery

Phase 4

Recruiting

Led By Rajrishi Sharma, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Patients scheduled for elective unilateral TKA

Planned for regional anesthesia for the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours after surgery

Awards & highlights

Study Summary

This trial seeks to evaluate whether adding a regional nerve block (iPACK) to a standard multimodal analgesia regimen (ACB + LIA) during and after total knee arthroplasty can provide improved pain relief and shorter hospital stay.

Who is the study for?

This trial is for adults over 18 who are scheduled for elective knee replacement surgery and can receive regional anesthesia. It's not suitable for those with allergies to local anesthetics, severe liver or kidney issues, chronic opioid use, neurological problems in the legs, or difficulty understanding pain scales.Check my eligibility

What is being tested?

The study tests if adding an iPACK block (a type of numbing medication around the knee) to standard pain control methods improves comfort after knee surgery. Participants will either get a real iPACK block with bupivacaine or a sham block with saline.See study design

What are the potential side effects?

Possible side effects from the iPACK block may include temporary numbness or weakness in the leg, infection at injection site, bleeding, allergic reactions to medications used, and less commonly nerve damage.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a knee replacement surgery on one knee.

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I am scheduled to receive regional anesthesia for my procedure.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Knee

Pain

Comparing patient satisfaction using Knee Society Scoring (KSS)

+4 more

Secondary outcome measures

Comparing duration (in minutes) of tourniquet use during surgery between two groups

Incidence of other unanticipated complications of iPACK intervention by a questionnaire filled out by the attending anesthesiologist

Incidence of technical difficulties experienced by a questionnaire filled out by the attending anesthesiologist on the day of surgery

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Real IPACK block.Active Control1 Intervention

This groups will receive the adductor canal block with the local anesthetic (15 mL of 0.25% bupivacaine + 2.5 mcg/mL epinephrine + 50 mcg/mL preservative-free dexamethasone) and local infiltration of analgesia + real iPACK block with 20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone

Group II: Sham iPACK blockPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,034 Total Patients Enrolled

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,546 Total Patients Enrolled

Alberta Hip and Knee ClinicOTHER

3 Previous Clinical Trials

238 Total Patients Enrolled

Media Library

Real iPACK block (Local Anesthesia) Clinical Trial Eligibility Overview. Trial Name: NCT04635176 — Phase 4

Postoperative Pain Research Study Groups: Sham iPACK block, Real IPACK block.

Postoperative Pain Clinical Trial 2023: Real iPACK block Highlights & Side Effects. Trial Name: NCT04635176 — Phase 4

Real iPACK block (Local Anesthesia) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04635176 — Phase 4

Frequently Asked Questions

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

To what degree does Real IPACK block constitute a hazard for individuals?

"The Real IPACK block has been approved, thus it receives a maximum safety rating of 3 on our scale."

Answered by AI

What are the common indications for Real IPACK block?

"Real IPACK block is a potential remedy for ophthalmia and sympathetic, as well as branch retinal vein occlusion, laryngotracheobronchitis, and macular edema."

Answered by AI

Am I qualified to partake in this research endeavor?

"For this research trial, participants must possess osteoarthritis and be between 18 to 80 years old. A total of 120 individuals are being sought out for the study."

Answered by AI

Are elderly individuals included in the criteria for this experiment?

"This trial is open to people aged 18-80. However, there are separate trials for individuals younger than 18 (189) and seniors above 65 years old (1635)."

Answered by AI

How many participants are recruited for this research project?

"Affirmative. The clinical trial is open for recruitment, according to data available on clinicaltrials.gov. This study was posted on October 30th 2022 and the most recent update came out of May 8th 2023; they are looking to enroll 120 patients at one site."

Answered by AI

What goals is this research endeavor trying to accomplish?

"The primary assessment of this trial occurs up to 24 hours after surgery and is conducted through the Knee Society Scoring system. Secondary measures include duration of tourniquet use, number of participants returning to the emergency room in hospital care, as well as any unanticipated complications recorded by a questionnaire filled out by attending anesthesiologists."

Answered by AI

Are there still possibilities for individuals to join this investigation?

"Affirmative. According to the information accessible on clinicaltrials.gov, this study is currently seeking volunteers and was initially announced in October of 2022 with a recent update occurring on May 8th 2023. The trial requires 120 participants at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Local Anesthesia With and Without iPACK Block

Rajrishi Sharma 2022. "Comparing Local Anesthesia With and Without iPACK Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04635176.

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