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Pain Control Following Total Hip Arthroplasty

Primary Purpose

Chronic Postoperative Pain

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride 0.25% Injection Solution_#2
EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge
Bupivacaine Hydrochloride 0.5% Injection Solution_#2
Ketorolac
Sponsored by
St. Mary's Research Center, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Mary's Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

Sham Comparator

Arm Label

Suprainguinal fascia iliaca compartment block (FICB)

Pericapsular nerve group block (PENG)

Local analgesia infiltration (LAI)

No adjunct: spinal anaesthesia (control)

Arm 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 nerve.

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.

local anesthetic infiltration (LAI) into the anterior pericapsular tissues

Standard spinal anesthesia technique

Outcomes

Primary Outcome Measures

Visual analog pain scale (VAS)
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

Secondary Outcome Measures

Patient satisfaction with pain control
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.

Full Information

First Posted
September 20, 2021
Last Updated
October 13, 2023
Sponsor
St. Mary's Research Center, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05062356
Brief Title
Pain Control Following Total Hip Arthroplasty
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Mary's Research Center, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suprainguinal fascia iliaca compartment block (FICB)
Arm Type
Experimental
Arm 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 nerve.
Arm Title
Pericapsular nerve group block (PENG)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Local analgesia infiltration (LAI)
Arm Type
Sham Comparator
Arm Description
local anesthetic infiltration (LAI) into the anterior pericapsular tissues
Arm Title
No adjunct: spinal anaesthesia (control)
Arm Type
Sham Comparator
Arm Description
Standard spinal anesthesia technique
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.25% Injection Solution_#2
Intervention Description
40cc
Intervention Type
Drug
Intervention Name(s)
EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge
Intervention Description
10cc
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.5% Injection Solution_#2
Intervention Description
20cc
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
15mg
Primary Outcome Measure Information:
Title
Visual analog pain scale (VAS)
Description
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
Time Frame
At 4 hours
Secondary Outcome Measure Information:
Title
Patient satisfaction with pain control
Description
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.
Time Frame
at 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Anthony Albers
Phone
514 345 3511
Ext
3282
Email
anthony.albers@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Park
Email
jin.patrick.park@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Anthony Albers, MDCM, FRCSC
Organizational Affiliation
McGill University, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Mary's Hospital Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandhya Baskaran
Phone
514 345 3511
Ext
3902
Email
sandhya.baskaran.comtl@ssss.gouv.qc.ca

12. IPD Sharing Statement

Learn more about this trial

Pain Control Following Total Hip Arthroplasty

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