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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
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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 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

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.

Find a Location

Who is running the clinical trial?

St. Mary's Research Center, CanadaLead Sponsor
9 Previous Clinical Trials
1,495 Total Patients Enrolled
Dr. Anthony Albers, MDCM, FRCSCPrincipal InvestigatorMcGill University, Department of Surgery

Media Library

Bupivacaine Hydrochloride 0.25% Injection Solution_#2 Clinical Trial Eligibility Overview. Trial Name: NCT05062356 — Phase 1
Postoperative Pain Research Study Groups: Suprainguinal fascia iliaca compartment block (FICB), Pericapsular nerve group block (PENG), Local analgesia infiltration (LAI), No adjunct: spinal anaesthesia (control)
Postoperative Pain Clinical Trial 2023: Bupivacaine Hydrochloride 0.25% Injection Solution_#2 Highlights & Side Effects. Trial Name: NCT05062356 — Phase 1
Bupivacaine Hydrochloride 0.25% Injection Solution_#2 2023 Treatment Timeline for Medical Study. Trial Name: NCT05062356 — Phase 1
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