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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

Must not have

Patients classified as American Society of Anesthesiologists score 3 or 4

Allergy to local anesthetics or any of the study medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours after surgery

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Approved for 60 Other Conditions

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious but not life-threatening illness according to the ASA score.

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I am allergic to local anesthetics or study drugs.

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I have nerve issues in my legs.

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I cannot have certain types of anesthesia due to health reasons.

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I have severe liver or kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee

Pain

Comparing patient satisfaction using Knee Society Scoring (KSS)

+4 more

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 8Eligibility criteria met