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

Trial Summary

What is the purpose of this 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 periacetabular osteotomy (PAO). The main questions to answer here are: 1. Does PLIA impact post-operative pain after PAO? 2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO? 3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart. Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

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.

What data supports the effectiveness of the treatment Peri-incisional Local Infiltrative Anesthesia (PLIA) for hip dysplasia surgery?

Research on similar treatments, like local infiltration anesthesia (LIA) used in hip surgeries, suggests that it can help manage pain effectively. For example, a study found that using LIA with ropivacaine improved recovery quality after hip arthroplasty, indicating potential benefits for pain relief in hip dysplasia surgery. ^{1 2 3 4 5}

How is Peri-incisional Local Infiltrative Anesthesia (PLIA) different from other treatments for hip dysplasia surgery?

Peri-incisional Local Infiltrative Anesthesia (PLIA) is unique because it involves directly injecting anesthetic around the surgical incision site, which can provide targeted pain relief and potentially reduce the need for additional pain medications after hip dysplasia surgery. ^{2 3 5 6 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Extrapedicular Infiltration Anesthesia as an Improved Method of Local Anesthesia for Unipedicular Percutaneous Vertebroplasty or Percutaneous Kyphoplasty. [2018]

3. Sweden 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pain After Preoperative Ultrasound Guided Hip Injections for Total Hip Arthroplasty: A Pilot Randomized Controlled Trial. [2023]

5. England 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. [2021]

6. England 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. [2021]

7. United States 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. [2023]