iPACK Block for Postoperative Pain in Knee Surgery

Recruiting in Palo Alto (17 mi)

Overseen byRajrishi Sharma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Calgary

Prior Safety Data

Trial Summary

What is the purpose of this trial?Total knee arthroplasty is an effective surgical intervention for patients with chronic osteoarthritis commonly performed worldwide. Postoperative pain management has been a key focus in patient care for this procedure. Poorly controlled pain following total knee arthroplasty is associated with decreased ambulation, increased length of hospital stay, increased complications (particularly related to significant opioid use), and overall suboptimal patient recovery. Appropriate postoperative pain management utilizing motor sparing peripheral nerve blocks and periarticular injections has been shown to provide faster, more optimized patient recovery and reduced hospital length of stay in patients undergoing total knee arthroplasty. Adductor canal block (ACB) is a well-studied peripheral nerve block performed for analgesia following total knee arthroplasty. ACB is an effective component of multimodal analgesia providing improved pain control to the peripatellar and intra-articular aspect of the knee joint while largely preserving the strength of the quadriceps muscles1. In addition, perioperative local infiltration analgesia (LIA) performed by the orthopaedic surgical team is a common practice that has been shown to improve short-term postoperative pain relief and reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty. The Infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block is a newly described regional anesthesia technique for postoperative analgesia in total knee arthroplasty, performed under ultrasound guidance. It targets the articular branches of the tibial, common peroneal, and obturator nerves in the popliteal region, and aims to provide analgesia to the posterior aspect of the knee joint without compromising lower extremity motor function following total knee arthroplasty. This study aims to determine whether the IPACK block provides additional analgesia (in combination with ACB + LIA) for total knee arthroplasty surgeries. The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty, which uses ACB + LIA, both modalities that have reasonable existing evidence.

Eligibility Criteria

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.

Inclusion Criteria

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

I am scheduled to receive regional anesthesia for my procedure.

I am 18 years old or older.

Exclusion Criteria

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

I am allergic to local anesthetics or study drugs.

You regularly take opioid pain medication.

+5 more

Participant Groups

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.

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