Regional Anesthesia vs Injection for Postoperative Pain

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Washington University School of Medicine

Must not be taking: Opioids, Gabapentin, Pregabalin

Disqualifiers: BMI > 45, Neurologic disorders, Hepatic or renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for managing pain after knee replacement surgery. It compares a combination of regional anesthesia—numbing specific nerves with the Adductor Canal Block plus IPACK Block—and local injections to using only local injections. The goal is to determine which method provides better pain relief and aids in easier movement post-surgery. This trial may suit individuals planning a knee replacement on one knee and who are comfortable using a smartphone or tablet to track their recovery. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you use opioids, gabapentin, or pregabalin more than 5 days a week, you cannot participate.

What is the safety track record for these treatments?

Earlier studies have shown that using the adductor canal block with the IPACK block is safe for managing pain after knee surgery. Research indicates that this combination improves pain relief without adding extra risk compared to the adductor canal block alone.

Studies have demonstrated that injections around the joint effectively reduce post-surgery pain without increasing the risk of side effects. Patients experienced less pain and required fewer painkillers, with no rise in issues like nausea or infections.

Both treatments have been well-tolerated, with no major side effects reported, suggesting they are safe options for managing pain after knee surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about comparing regional anesthesia with periarticular injections for managing postoperative pain. Unlike standard treatments like oral pain medications or nerve blocks alone, this approach combines an Adductor Canal Block and IPACK Block with a periarticular injection. This combination targets specific nerves and tissues around the joint, potentially offering more precise pain relief and reducing the need for systemic pain medication. The hope is that this method will provide better pain management with fewer side effects, improving recovery times for patients.

What evidence suggests that this trial's treatments could be effective for postoperative pain relief following knee arthroplasty?

This trial will compare the effectiveness of two approaches for postoperative pain management. One treatment arm will use both the adductor canal block and IPACK block together. Research shows this combination can reduce pain after knee replacement surgery. Studies have found that it leads to less pain, a lower need for strong painkillers like opioids, and quicker recovery of movement compared to some other methods. Specifically, one study found that patients who received this combination felt less pain in the hours immediately following surgery. The other treatment arm will use periarticular injection alone. While some research shows no major difference in pain levels when comparing certain combinations, the overall evidence supports the dual-block approach for better pain management after surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Andrew Schneider, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals undergoing knee replacement surgery who need pain management post-operation. Participants should be suitable for regional anesthesia and have no conditions that would interfere with the study.

Inclusion Criteria

Willing to sign informed consent

Willing to return for all follow-up visits

Having a smartphone or tablet device capable of running the FocusMotion platform

Exclusion Criteria

Preexisting functionally limiting neurologic disorders

I regularly use opioids, gabapentin, or pregabalin more than 5 days a week.

I am scheduled for surgery under general anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either regional anesthesia (ACB + IPACK) and periarticular injection or periarticular injection alone

1 day

1 visit (in-person, day of surgery)

Postoperative Monitoring

Participants are monitored for pain relief and functional outcomes using VAS pain scores, step count, and other measures

2 weeks

Daily monitoring (virtual via app and Fitbit)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adductor Canal Block plus IPACK Block
• Periarticular Injection

Trial Overview The study compares two pain relief methods after knee surgery: one group receives a nerve block plus an injection around the knee, while the other gets just the injection. The goal is to see which method better reduces pain and improves early movement.

How Is the Trial Designed?

Group I: Block and Periarticular injection Active Control 2 Interventions

regional anesthesia (Adductor canal block +IPACK) and Periarticular injection

Group II: Periarticular injectin alone Active Control 1 Intervention

Periarticular injection alone

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12083146/

Comparative analysis of adductor canal block combined ... The A + I regimen demonstrated superior analgesic efficacy, reduced motor blockade, and earlier ambulation compared to S + F in TKA patients.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X25004180

Outcomes following use of IPACK Nerve Block No significant differences in VAS scores were found between experimental and control groups for IPACK+Adductor Canal Block (ACB) or IPACK+sham.

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(21)00790-7/abstract

Adductor Canal Block Combined With IPACK ... The primary outcome was postoperative pain score. The secondary outcome was opioid consumption. Other outcomes included functional evaluation ...

4. eurarchmedres.org eurarchmedres.org/article/EAMR-18199/pdf

Comparing the Effectiveness of Adductor Canal and ... The primary outcome compares analgesic efficacy at different time points (1st, 8th, and 24th hours post-block administration) between the ACB + IPACK block ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06265441?term=AREA%5BBasicSearch%5D(adductor%20canal%20block)&rank=7

Comparison of Pain Relief Post Knee Arthroscopy Using ... Comparison of IPACK Block with Adductor Canal Block Vs Adductor Canal Block Alone for Post Operative Analgesia Following Arthroscopic Knee Surgeries.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11748369/

Adductor Canal Block Combined With IPACK Block for ... This retrospective cohort study suggests that a combination of ACB and IPACK block may have a greater effect than PIA or ACB alone on analgesia following TKA.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03774966

IPACK and Adductor Canal Catheter Patient Outcomes for ... This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06086483

Pain Management After Adductor Canal Block for Total ... This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, ...

9. rapm.bmj.com rapm.bmj.com/content/50/Suppl_1/A327

P309 Adductor canal combined with iPACK blocks and ... This randomized controlled trial aimed to determine whether ACB combined with iPACK block offers superior postoperative analgesia compared to ACB alone. Methods ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652613/

Periarticular injection, iPACK block, and peripheral nerve ... The literature review indicates that the best analgesic effect is obtained by combining PAI or iPACK with a peripheral nerve block, particularly with ACB.