Local Anesthesia for Hip Dysplasia Surgery

(PILA PAO Trial)

Overseen By Ashley S Kochuyt

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Michael C Willey

Disqualifiers: Pregnancy, Prisoner, Allergy, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Surgery duration

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different methods of administering local anesthesia during surgery affect pain and the need for pain medication afterward. It focuses on patients with hip dysplasia, a condition where the hip joint is not properly aligned, who are undergoing periacetabular osteotomy (PAO). Researchers will compare three groups: those receiving peri-incisional local infiltrative anesthesia (PLIA) after surgery, those receiving it during surgery, and those not receiving it at all. Adolescents or young adults with hip dysplasia scheduled for PAO at the University of Iowa Hospital and Clinics are good candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using local anesthesia around the surgical area (PLIA) is generally safe for surgeries like hip and knee operations. In studies with 325 patients, this anesthesia effectively managed post-surgical pain without major safety concerns. One study found that local anesthesia in hip surgeries led to positive outcomes, such as lower death rates and fewer blood clots.

These findings suggest that PLIA is well-tolerated, with no significant side effects reported. Since this trial is in phases 2 and 3, the treatment has already passed early safety tests, indicating its safety for further testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Peri-incisional Local Infiltrative Anesthesia (PLIA) for hip dysplasia surgery because it offers a tailored approach to pain management. Unlike systemic pain medications, PLIA is administered directly around the incision site, potentially leading to more effective pain relief with fewer side effects. This method allows for two different approaches: one where the anesthesia is given after the surgical closure using a pediatric catheter, and another where it is administered throughout the surgery. Both strategies aim to enhance patient comfort and recovery by providing localized pain control precisely when it's needed most.

What evidence suggests that these anesthesia methods could be effective for post-operative pain management in hip dysplasia surgery?

Studies have shown that peri-incisional local infiltrative anesthesia (PLIA) effectively reduces short-term pain and shortens hospital stays for patients undergoing hip and knee surgeries. In this trial, researchers will administer PLIA in two ways: one group will receive it throughout the surgical procedure, while another group will receive it after the fascia has been closed. Research indicates that PLIA helps manage pain after operations like periacetabular osteotomy (PAO). Applied during or after surgery to numb the area, this anesthesia can reduce the need for pain medications. By lessening pain and the use of morphine-like drugs, PLIA can improve the recovery experience. This suggests that PLIA could be beneficial for managing pain after hip dysplasia surgeries. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 13 to 50 with hip dysplasia who are indicated for periacetabular osteotomy (PAO) surgery at the University of Iowa Hospital and Clinics.

Inclusion Criteria

I am diagnosed with hip dysplasia and need PAO surgery at the University of Iowa Hospital.

Exclusion Criteria

I am not having surgery for femoral osteotomy or hip dislocation.

Pregnant or breast-feeding individuals

Prisoner or ward of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Preoperative Assessment

Participants complete surveys including demographics, General Self-Efficacy Scale, and Pain Resilience Scale

1 day

1 visit (in-person)

Treatment

Participants undergo periacetabular osteotomy with or without peri-incisional local infiltrative anesthesia (PLIA)

Surgery duration

Post-operative Monitoring

Participants' pain and medication usage are monitored using VAS and MED until discharge

3 days

Follow-up

Participants may inquire about their study group at the standard-of-care 3-month follow-up visit

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Peri-incisional Local Infiltrative Anesthesia (PLIA)

Trial Overview The study tests different peri-incisional local infiltrative anesthesia (PLIA) methods in PAO surgery. It aims to see if PLIA affects post-operative pain, medication usage, and whether the timing of PLIA administration makes a difference.

How Is the Trial Designed?

Group I: Post Closure Active Control 1 Intervention

Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.

Group II: Throughout Procedure Active Control 1 Intervention

The injection will be performed throughout the surgical procedure.

Group III: Control Active Control 1 Intervention

No medication administration. Standard of care medications will be offered.

Peri-incisional Local Infiltrative Anesthesia (PLIA) is already approved in United States, European Union for the following indications:

Approved in United States as Local Infiltrative Anesthesia for:

• Post-operative pain management

Approved in European Union as Local Infiltrative Anesthesia for:

• Post-operative pain management

Who Is Running the Clinical Trial?

Michael C Willey

Lead Sponsor

Trials

4

Recruited

730+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Local infiltration anaesthesia (LIA) significantly reduces pain scores in the first 12 hours after total hip arthroplasty (THA) compared to a control group, enhancing patient satisfaction.

Both LIA in the deep and superficial fascia and LIA in all layers provide similar pain relief and satisfaction levels, suggesting that LIA in the deep and superficial fascia could be a viable alternative to the more extensive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effect of single-shot ropivacaine at different layers of the surgical site in primary total hip arthroplasty: a randomised, controlled, observer-blinded study. Xiao, Q., Xu, B., Wang, H., et al.[2021]

In a study of 64 patients undergoing peri-acetabular osteotomy, a higher pre-operative dose of dexamethasone (48 mg) did not significantly reduce moderate to severe pain compared to a standard dose of 8 mg, with 75% of the higher dose group and 66% of the lower dose group reporting pain above 3 on a numeric rating scale.

However, patients receiving the 48 mg dose required significantly less opioid medication in the first four postoperative days, indicating a potential benefit in reducing opioid consumption despite similar pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative recovery after peri-acetabular osteotomy: A double-blind, randomised single-centre trial of 48 vs. 8 mg dexamethasone. Steinthorsdottir, KJ., Awada, HN., Dirks, J., et al.[2021]

Extrapedicular infiltration anesthesia (EPIA) significantly reduced intraoperative pain compared to conventional local infiltration anesthesia (CLIA), with average pain scores of 2.5 for EPIA versus 4.3 for CLIA (P = 0.001) in a study of 44 patients with osteoporotic vertebral compression fractures.

EPIA eliminated the need for additional sedative analgesia during the procedure, while one patient in the CLIA group required it, indicating that EPIA may enhance patient comfort without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extrapedicular Infiltration Anesthesia as an Improved Method of Local Anesthesia for Unipedicular Percutaneous Vertebroplasty or Percutaneous Kyphoplasty. Liu, L., Cheng, S., Lu, R., et al.[2018]

Adults with hip dysplasia experience significantly worse pain, function, and quality of life compared to healthy individuals before undergoing periacetabular osteotomy (PAO), as shown in a meta-analysis of 62 studies.

Post-surgery, patients report significant improvements in pain, function, and quality of life at both 1 and 2 years after PAO, although their outcomes do not fully match those of healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain, function and quality of life are impaired in adults undergoing periacetabular osteotomy (PAO) for hip dysplasia: a systematic review and meta-analysis. O'Brien, MJ., Semciw, AI., Mechlenburg, I., et al.[2023]

In a study of 42 patients undergoing total hip arthroplasty (THA), adding a pre-incision intra-articular injection of local anesthetic did not show any significant benefits over the standard post-incision peri-articular injection alone in terms of postoperative outcomes.

The study suggests that while ultrasound-guided injections are a cost-effective method for administering local anesthetics, the combination of pre- and post-incision injections does not improve pain management or recovery metrics compared to the standard approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain After Preoperative Ultrasound Guided Hip Injections for Total Hip Arthroplasty: A Pilot Randomized Controlled Trial. Holbert, SE., Fowler, B., West, M., et al.[2023]

In a randomized trial involving 53 patients undergoing periacetabular osteotomy, local infiltration of ropivacaine did not significantly reduce postoperative pain or opioid consumption compared to a placebo (saline) over the first 4 days post-surgery.

The study suggests that the effectiveness of ropivacaine as a standalone treatment for postoperative pain relief is limited, prompting the need for further research into larger volume and multimodal pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients. Bech, RD., Ovesen, O., Lindholm, P., et al.[2021]

In a study involving 160 patients undergoing anterior total hip arthroplasty, local infiltration analgesia (LIA) with 0.2% ropivacaine did not significantly improve the quality of recovery on postoperative day 1 compared to a placebo of 0.9% saline, as measured by the QoR-15 score.

Secondary outcomes, including pain levels, opioid consumption, and mobilization, were also similar between the ropivacaine and placebo groups, indicating that LIA with ropivacaine may not provide additional benefits in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Local Infiltration Analgesia on the Quality of Recovery After Anterior Total Hip Arthroplasty: A Randomized, Triple-Blind, Placebo-Controlled Trial. Tan, NL., Gotmaker, R., Barrington, MJ.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4118275/

Local anaesthetic infiltration for peri-operative pain control in ... Local anaesthetic infiltration is effective in reducing short-term pain and hospital stay in patients receiving THR and TKR.

2. withpower.com withpower.com/trial/phase-2-and-3-developmental-dysplasia-of-the-hip-7-2024-2dd6a

Local Anesthesia for Hip Dysplasia Surgery (PILA PAO Trial) The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a ...

3. apm.amegroups.org apm.amegroups.org/article/view/84017/html

Comparison of the analgesic efficacy of periarticular infiltration ... PENG block provided comparable analgesia with PAI following THA. It is not conclusive that PENG is inferior or non-inferior to PAI based on our study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10350388/

Comparison between Ultrasound‐Guided Pericapsular ... We aimed to compare the analgesic effect of ultrasound‐guided PENG blocking and periarticular local infiltration analgesia after THA.

5. researchgate.net researchgate.net/publication/355916052_Effectiveness_of_peri-articular_infiltration_with_local_anesthetic_and_adjuvants_for_post-surgical_pain_control_in_total_knee_replacement

Effectiveness of peri-articular infiltration with local anesthetic and ... Results: 20 patients in each group, with a follow-up of 4 weeks. There were no significant differences in demographic characteristics between the two groups.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4095027/

Perioperative outcomes and type of anesthesia in hip surgical ... Most studies concur on a positive outcome in overall mortality, thromboembolic events, blood loss and transfusion requirements when comparing regional to ...

7. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2021.730261/full

Local Perianal Anesthetic Infiltration Is Safe and Effective ... Conclusions: Local anesthesia using posterior perineal block technique is safe and effective for intraoperative analgesia in anorectal surgery, ...