What is the mechanism of action of this treatment?

Local anesthetic infiltration (LAI) works by directly injecting anesthetics into the surgical site, blocking sodium ion channels to prevent nerve signal transmission and thus reducing pain. The pericapsular nerve group (PENG) block targets the nerves supplying the hip joint, providing focused pain relief by similarly blocking nerve signal transmission. The suprainguinal fascia iliaca compartment block (FICB) involves injecting anesthetics near the iliac fascia to block multiple nerves in the pelvic region. These treatments are crucial for postoperative pain patients as they provide targeted pain relief, reduce the need for systemic opioids, and facilitate faster recovery and mobilization.

What side effects are associated with this type of intervention?

The most common treatments for postoperative pain, such as Local Anesthetic Infiltration (LAI), Pericapsular Nerve Group (PENG) block, and Fascia Iliaca Compartment Block (FICB), generally have a favorable safety profile. However, potential side effects include local site reactions such as bruising, swelling, and infection. Systemic side effects, though rare, can include allergic reactions, toxicity leading to central nervous system symptoms (e.g., dizziness, seizures), and cardiovascular issues (e.g., hypotension, arrhythmias). These treatments aim to reduce the need for opioids, thereby minimizing opioid-related side effects such as nausea, vomiting, constipation, and respiratory depression.

What prior FDA approvals exist?

The FDA has approved several local anesthetics and nerve block techniques for the treatment of postoperative pain. Commonly used local anesthetics include lidocaine, bupivacaine, and ropivacaine, which are often administered through Local Anesthetic Infiltration (LAI) or nerve blocks such as the Pericapsular Nerve Group (PENG) block and the Suprainguinal Fascia Iliaca Compartment Block (FICB). These methods aim to provide effective pain relief while minimizing the need for systemic opioids, thereby reducing associated side effects. Additionally, encapsulated formulations of local anesthetics, like encapsulated lidocaine, have been studied for prolonged pain relief.

What other types of research exist?

Promising novel alternatives for postoperative pain management in 2024 include: 1) Spinal cord stimulation (SCS), which has shown efficacy in chronic pain management and is being explored for postoperative pain. 2) Intranasal lidocaine, which has been effective in acute migraine treatment and may offer rapid pain relief. 3) Acupuncture, particularly electroacupuncture, which has demonstrated pain relief through neurostimulation. 4) Repetitive transnasal sphenopalatine ganglion blockade, which has shown promise in chronic migraine and could be adapted for postoperative pain.

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Pain Management Drugs for Postoperative Hip Surgery Pain

Phase 1

Waitlist Available

Led By Dr. Anthony Albers, MDCM, FRCSC

Research Sponsored by St. Mary's Research Center, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥18 years old) who require an inpatient primary total hip arthroplasty under spinal anesthesia

Be older than 18 years old

Must not have

Anesthesia other than spinal (general, epidural, other)

Previous surgery to the affected hip

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4 hours

Summary

This trial compares three methods of pain relief after hip replacement surgery in elderly patients with severe arthritis. The methods aim to block pain signals from the hip area, helping patients recover faster and reducing the need for strong painkillers.

Who is the study for?

This trial is for adults over 18 needing a primary total hip replacement under spinal anesthesia. They must be able to give written consent and understand English or French. It's not for those with a BMI over 45, allergies to the drugs being tested, previous fractures or surgeries on the affected hip, other diagnoses causing significant deformity, or daily opioid use before surgery.

What is being tested?

The study tests different pain control methods after hip replacement surgery. It compares local anesthetic infiltration (LAI), nerve blocks (PNBs), NSAIDs like Ketorolac, and other analgesics to see which combination reduces postoperative pain effectively and minimizes narcotic use.

What are the potential side effects?

Possible side effects include reactions at the injection site from Bupivacaine or Prilocaine such as redness or swelling, increased heart rate from EPINEPHrine, stomach issues from Ketorolac like nausea or ulcers, and general risks of numbness or weakness from nerve blocks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult needing a hip replacement surgery under spinal anesthesia.

Exclusion Criteria

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

Select...

I will receive anesthesia that is not spinal for my procedure.

Select...

I have had surgery on my hip before.

Select...

I am having a hip replacement due to a fracture.

Select...

My condition is not osteoarthritis but another that significantly deforms my hip joint.

Select...

I take opioid painkillers every day.

Select...

I have had a fracture in the area now affected.

Select...

I need surgery to correct a previous operation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4 hours

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

Treatment Details

Study Objectives

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

Primary study objectives

Visual analog pain scale (VAS)

Secondary study objectives

Patient satisfaction with pain control

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Suprainguinal fascia iliaca compartment block (FICB)Experimental Treatment3 Interventions

Suprainguinal fascia iliaca compartment block (FICB) is a technique that involves injection of local anesthetics underneath the fascia of the iliacus muscle to block the femoral nerve, the lateral femoral cutaneous nerve and, possibly, the obturator nerve.

Group II: Pericapsular nerve group block (PENG)Active Control3 Interventions

The pericapsular nerve group block (PENG) is a technique that involves injection of local anesthetic in the musculofascial plane between the psoas muscle and the superior pubic ramus.

Group III: Local analgesia infiltration (LAI)Placebo Group3 Interventions

local anesthetic infiltration (LAI) into the anterior pericapsular tissues

Group IV: No adjunct: spinal anaesthesia (control)Placebo Group2 Interventions

Standard spinal anesthesia technique

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine Hydrochloride 0.25% Injection Solution_#2

2021

Completed Phase 1

~240

EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge

2021

Completed Phase 1

~240

Ketorolac

2014

Completed Phase 4

~1760

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Local anesthetic infiltration (LAI) works by directly injecting anesthetics into the surgical site, blocking sodium ion channels to prevent nerve signal transmission and thus reducing pain. The pericapsular nerve group (PENG) block targets the nerves supplying the hip joint, providing focused pain relief by similarly blocking nerve signal transmission. The suprainguinal fascia iliaca compartment block (FICB) involves injecting anesthetics near the iliac fascia to block multiple nerves in the pelvic region. These treatments are crucial for postoperative pain patients as they provide targeted pain relief, reduce the need for systemic opioids, and facilitate faster recovery and mobilization.

Duration of spinal anaesthesia is determined by the partition coefficient of local anaesthetic.Predictive value of a diagnostic block in focal nerve injury with neuropathic pain when surgery is considered.Lipid emulsion in local anesthetic toxicity.