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Pain Management Drugs for Postoperative Hip Surgery Pain

Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 hours
Awards & highlights

Study Summary

This trial is testing different combinations of drugs to see what works best for pain management following total hip arthroplasty.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual analog pain scale (VAS)
Secondary outcome measures
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
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Who is running the clinical trial?

St. Mary's Research Center, CanadaLead Sponsor
8 Previous Clinical Trials
1,465 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What empirical evidence is available about the efficacy of Bupivacaine Hydrochloride 0.25% Injection Solution_#2 in clinical trials?

"At present, there are 159 ongoing clinical trials for Bupivacaine Hydrochloride 0.25% Injection Solution_#2 and 31 of them have moved to the third phase of development. Germantown, Tennessee is hosting a few of these studies while 228 other locations across America also offer access to this medication's evaluation process."

Answered by AI

Are there any opportunities to participate in this research endeavor?

"According to clinicaltrials.gov, this investigation is in search of potential patients. The study was initially announced on November 4th 2021 and the details were last modified on October 24th 2022."

Answered by AI

What type of maladies is Bupivacaine Hydrochloride 0.25% Injection Solution_#2 commonly used to treat?

"Bupivacaine Hydrochloride 0.25% Injection Solution_#2 is employed to address unresponsive bradycardia, as well as pathologies such as pemphigus, pupil irregularity and lupus erythematosus cell proliferation."

Answered by AI

Can you provide a breakdown of the possible risks associated with Bupivacaine Hydrochloride 0.25% Injection Solution_#2?

"With limited data on safety and efficacy, our team at Power has assigned Bupivacaine Hydrochloride 0.25% Injection Solution_#2 a rating of 1 out of 3."

Answered by AI

How many individuals have signed up to partake in this investigation?

"Affirmative. Clinicaltrials.gov data validates that this clinical trial is currently searching for participants, having first been posted on November 4th 2021 and last updated October 24th 2022. The research endeavour aims to gather information from 240 individuals at one medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Pain Control Following Total Hip Arthroplasty
Anthony Albers, MD 2021. "Pain Control Following Total Hip Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05062356.
~0 spots leftby Apr 2024
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