- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05062356
Pain Control Following Total Hip Arthroplasty
Prospective Randomized Study Comparing Suprainguinal Fascia Iliaca Block vs. Pericapsular Nerve Group Block vs. Local Anesthetic Infiltration vs. Spinal Anesthetic Without Adjuncts for Pain Control Following Total Hip Arthroplasty
Total hip arthroplasty (THA) is one of the most common surgical procedures performed in elderly patients, with its main indication being end-stage osteoarthritis of the hip1. It is estimated that over 572,000 patients per year will undergo THA in the USA alone by 20301 and postsurgical pain associated with THA remains a significant issue. Postoperative pain is associated with delayed joint mobilization, ambulation, patient satisfaction and can often delay the patient's discharge home1.
Multimodal analgesia for the management of postoperative pain following THA is now standard of care2,3. It involves a combination of local anesthetic infiltration (LAI), peripheral nerve blocks (PNBs), analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and/or other medications, including gabapentinoids and opioids. Using multiple analgesic modalities allows for an easier and faster recovery for THA patients and ultimately allows for reduction in postoperative narcotic use and it's associated negative side effects. Total hip arthroplasty can be performed under either general anesthesia, epidural anesthesia or most commonly under spinal anesthesia, with or without epidural morphine. The adjunctive use of LAI, pericapsular nerve group (PENG) block or suprainguinal fascia iliaca compartment block (FICB) for postoperative pain management is becoming more widespread, although evidence on their efficacy has been inconsistent4-8. As such, comparative evaluation of these adjuctive analgesic modalities is imperative to optimize postoperative pain management following THA.
Study Overview
Status
Conditions
Detailed Description
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 nerve9. 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. Evidence to date shows that FICB and PENG may be effective modalities to provide postoperative pain control following THA and could reduce opioid consumption10. The above procedures have been documented as safe and effective when performed by a qualified anesthetist but come with various risks (potential motor / sensory blocade especially) and associated cost. Alternatively, or in conjunction to the above procedures, the orthopedic surgeon can perform local anaesthetic infiltration (LAI) into the anterior pericapsular tissues. To date, no study has compared the efficacy of FICB, PENG block and LAI in a randomized study, therefore a preferred postoperative analgesic regimen has yet to be determined.
In this randomized trial, the investigators aim to evaluate postoperative pain and side effects related to pain control in patients who receive FICB versus LAI versus PENG block following THA. The investigators aim to compare these procedures between each other and assertain whether these techniques compare favourably to spinal anesthetic as a control group.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Dr. Anthony Albers
- Phone Number: 3282 514 345 3511
- Email: anthony.albers@mail.mcgill.ca
Study Contact Backup
- Name: Patrick Park
- Email: jin.patrick.park@mail.mcgill.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T 1M5
- Recruiting
- St. Mary's Hospital Center
-
Contact:
- Sandhya Baskaran
- Phone Number: 3902 514 345 3511
- Email: sandhya.baskaran.comtl@ssss.gouv.qc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (≥18 years old) who require an inpatient primary total hip arthroplasty under spinal anesthesia
- Written consent
- Any gender
Exclusion Criteria:
- Patients who require revision surgery
- Anesthesia other than spinal (general, epidural, other)
- Body mass index (BMI) > 45 kg/m2
- Allergies to study medication
- Previous fracture to affected area
- Previous surgery to the affected hip
- Diagnosis other than osteoarthritis (avascular necrosis, significant deformity such as post-Perthes, slipped capital femoral epiphysis, dysplasia classified as Crowe 3 or 4, or other diagnoses causing significant deformity of the femoral head or acetabulum)
- THA for hip fractures
- Patients taking daily opiod analgesics pre-operatively
- Anesthetist on day of surgery who does not perform FICB and PENG and no alternate anesthetist available to perform the block
- Patients who do not understand, read or communicate in either French or English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Suprainguinal fascia iliaca compartment block (FICB)
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.
|
40cc
10cc
15mg
|
Active Comparator: Pericapsular nerve group block (PENG)
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.
|
10cc
15mg
20cc
|
Sham Comparator: Local analgesia infiltration (LAI)
local anesthetic infiltration (LAI) into the anterior pericapsular tissues
|
40cc
10cc
15mg
|
Sham Comparator: No adjunct: spinal anaesthesia (control)
Standard spinal anesthesia technique
|
15mg
20cc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog pain scale (VAS)
Time Frame: At 4 hours
|
The primary outcome was chosen as VAS at 4 hours post-op.
The investigators debated between VAS score and narcotic consumption, as both have their limitations.
VAS score, which is used as primary outcome in most similar studies1, 4-9 can be affected by narcotic consumption and vice-versa.
Narcotic consumption is also variable given the need for patients to ask for the medication (with the subjective nature of pain tolerance) and requirement that nursing be available to administer it while in hospital.
Some studies have attempted to circumvent these limitations by utilizing patient controlled analgesia (PCA) pumps.
The researchers wanted to avoid this because it does not reflect current clinical practice.
Therefore, VAS was chosen at 4 hours, a time frame where the spinal effect is likely diminished, the blocks are most effective, the need for breakthrough narcotics is low, being in line with the current literature
|
At 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction with pain control
Time Frame: at 4 hours
|
Secondary outcome measures include patient satisfaction with pain control at the above mentioned time points using a four point Likert scale, the need for breakthough opioids in the first 4 hours, the number of morphine equivalents consumed for the first 48 hours post-op and length of hospital stay.
Complications related to anesthesia such as motor nerve block (femoral or sciatic), any perceived peripheral sensory changes, urinary retention, post-operative nausea/vomiting or signs/symptoms of local anaesthetic toxicity will be documented.
|
at 4 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr. Anthony Albers, MDCM, FRCSC, McGill University, Department of Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Ketorolac
- Pharmaceutical Solutions
- Prilocaine
- Bupivacaine
- Epinephrine
Other Study ID Numbers
- SMHC - 21- 02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Postoperative Pain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, Chronic | Video-Assisted Thoracoscopic SurgeryTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Hospital of South West JutlandNovo Nordisk A/SRecruitingPhysical Activity | Postoperative Pain, Acute | Postoperative Pain, Chronic | Bariatric Surgery | MobilizationDenmark
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Consorci Sanitari de TerrassaRecruitingChronic Pain | Cesarean Section Complications | Chronic Post Surgical PainSpain
-
Ankara UniversityCompletedThoracotomy | Chronic Pain SyndromeTurkey
-
Danish Pain Research CenterDOLORisk Consortium; Aarhus University HospitalCompletedChronic Neuropathic Pain, Postoperative | Chronic Pain, Postoperative | Chronic Chemotherapy-induced Neuropathic Pain | Chronic Chemotherapy-induced Pain | Chronic Chemotherapy-induced Peripheral NeuropathyDenmark
-
Danish Pain Research CenterDOLORisk Consortium; Aarhus University HospitalCompletedChronic Neuropathic Pain, Postoperative | Chronic Pain, Postoperative | Chronic Chemotherapy-induced Neuropathic Pain | Chronic Chemotherapy-induced Pain | Chronic Chemotherapy-induced Peripheral NeuropathyDenmark
Clinical Trials on Bupivacaine Hydrochloride 0.25% Injection Solution_#2
-
Theodor Bilharz Research InstituteCompletedPain, Postoperative | Ultrasound Guided Rectus Sheath BlockEgypt
-
Sindh Institute of Urology and TransplantationCompletedPost Operative PainPakistan
-
Jon I. EinarssonGeorge Washington University; University of North CarolinaCompleted
-
Kasr El Aini HospitalCompletedPain Management | Anesthesia | PediatricsEgypt
-
Istanbul UniversityCompletedPain, PostoperativeTurkey
-
University Hospitals Cleveland Medical CenterWithdrawnNeonatal Neurobehavior | Breastfeeding OutcomesUnited States
-
The University of Texas Health Science Center at...Recruiting
-
University of North Carolina, Chapel HillCompletedPain, PostoperativeUnited States
-
Assiut UniversityCompletedFracture; Rib, MultipleEgypt
-
King Edward Medical UniversityCompletedPostoperative PainPakistan