Chronic Postoperative PainPhase 1NCT05062356
Pain Control Following Total Hip Arthroplasty
A Phase 1 study testing Bupivacaine Hydrochloride 0.25% Injection Solution_#2, EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge and Bupivacaine Hydrochloride 0.5% Injection Solution_#2 in people with Chronic Postoperative Pain, run by St. Mary's Research Center, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- Bupivacaine Hydrochloride 0.25% Injection Solution_#2, EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge and Bupivacaine Hydrochloride 0.5% Injection Solution_#2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2021to 15 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old) who require an inpatient primary total hip arthroplasty under spinal anesthesia
- Written consent
- Any gender
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Postoperative Pain
- Being tested
- 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
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride 0.25% Injection Solution_#2Drug
40cc
EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML CartridgeDrug
10cc
Bupivacaine Hydrochloride 0.5% Injection Solution_#2Drug
20cc
KetorolacDrug
15mg
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal fascia iliaca compartment block (FICB) | Experimental | 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. Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution_#2; Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge; Drug: Ketorolac |
| Pericapsular nerve group block (PENG) | Active comparator | 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. Receives: Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#2; Drug: Ketorolac |
| Local analgesia infiltration (LAI) | Sham comparator | local anesthetic infiltration (LAI) into the anterior pericapsular tissues Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution_#2; Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge; Drug: Ketorolac |
| No adjunct: spinal anaesthesia (control) | Sham comparator | Standard spinal anesthesia technique Receives: Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#2; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 4 hours
Secondary outcomes (1)
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.
Measured: at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start4 Nov 2021
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Mary's Research Center, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Albers, MD, St. Mary's Research Center, Canada
- Investigators
- Dr. Anthony Albers, MDCM, FRCSC, Principal investigator, McGill University, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062356
- Sponsor's protocol ID
- SMHC - 21- 02
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05062356
- Acronym / sponsor ID
- SMHC - 21- 02
- Conditions
- Chronic Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- St. Mary's Research Center, CanadaUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal fascia iliaca compartment block (FICB) | Experimental | Drug: Bupivacaine Hydrochloride 0.25% Injection Solution_#2, Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge, Drug: KetorolacSuprainguinal 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. |
| Pericapsular nerve group block (PENG) | Active comparator | Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge, Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#2, Drug: KetorolacThe 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 analgesia infiltration (LAI) | Sham comparator | Drug: Bupivacaine Hydrochloride 0.25% Injection Solution_#2, Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge, Drug: Ketorolaclocal anesthetic infiltration (LAI) into the anterior pericapsular tissues |
| No adjunct: spinal anaesthesia (control) | Sham comparator | Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#2, Drug: KetorolacStandard spinal anesthesia technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years old) who require an inpatient primary total hip arthroplasty under spinal anesthesia
- Written consent
- Any gender
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Hydrochloride 0.25% Injection Solution_#240cc | Drug | Local analgesia infiltration (LAI), Suprainguinal fascia iliaca compartment block (FICB) |
| EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge10cc | Drug | Local analgesia infiltration (LAI), Pericapsular nerve group block (PENG), Suprainguinal fascia iliaca compartment block (FICB) |
| Bupivacaine Hydrochloride 0.5% Injection Solution_#220cc | Drug | No adjunct: spinal anaesthesia (control), Pericapsular nerve group block (PENG) |
| Ketorolac15mg | Drug | Local analgesia infiltration (LAI), No adjunct: spinal anaesthesia (control), Pericapsular nerve group block (PENG), Suprainguinal fascia iliaca compartment block (FICB) |
Primary outcome
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
1 secondary outcome
Patient satisfaction with pain control
Time frame: at 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Anthony Albers, MDCM, FRCSC principal investigator
McGill University, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine Hydrochloride 0.25% Injection Solution_#2, EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge and Bupivacaine Hydrochloride 0.5% Injection Solution_#2 in people with Chronic Postoperative Pain, run by St. Mary's Research Center, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog pain scale (VAS) (time frame: At 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.