Total Hip Replacement SurgeryPENGNCT04245280
Effectiveness of PENG Block Combined to LFCN Block on the Quality of Recovery After Total Hip Replacement
A study testing Ropivacaine 0.5% Injectable Solution and Saline Solution in people with Total Hip Replacement Surgery and Postoperative Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The main objective of this study is to evaluate the effectiveness of the association of PENG and LFCN blocks on the quality of recovery 24 hours after total hip replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement Surgery, Postoperative Pain
- What is being tested?
- Ropivacaine 0.5% Injectable Solution and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2021to 31 Jul 2024
- Phase
- Interventional
- 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
- Patients over 18 years old undergoing a total hip replacement surgery
Who cannot join
- Contraindication to regional anesthesia (allergy to local anesthetics, severe coagulopathy, infection in the designated area, pre-existing neuropathy in the obturator or femoral territory)
- Contraindication to spinal anesthesia
- Patient's refusal or inability to consent
- Opioid use on a regular basis pre-operatively
- Inability to communicate with medical team or research team
- Inability to understand the items of the multiple forms
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Effectiveness of Pericapsular Nerve Group (PENG) Block Combined to Lateral Femoral Cutaneous Nerve (LFCN) Block on the Quality of Recovery After Total Hip Replacement
The main objective of this study is to evaluate the effectiveness of the association of PENG and LFCN blocks on the quality of recovery 24 hours after total hip replacement surgery.
Read the detailed description
Total hip replacement is a frequent procedure in the geriatric population associated with moderate post-operative pain. It is known that a sub-optimal analgesia is associated with a delayed mobilization leading to a longer hospital stay, poor functional recovery and increased thromboembolic complications. Moreover, opioid analgesia, especially in the geriatric population, increases the incidence of delirium.
Multimodal analgesia, combining different analgesic classes and regional anesthesia, is preferable than relying mainly on opioids, improving the outcomes in the post-operative period. Until now, no regional anesthesia technique has proven itself to be better than the others, each having its limitations. While the local anesthetic doses are high with the peri-articular infiltration under direct visualisation, the epidural is associated with bilateral block and sympathetic block. Also, the lumbar plexus block is a technically difficult block and is associated with a motor block. Finally, other blocks such as the femoral, 3:1 or fascia iliaca are not blocking the totality of the nerves involved in the post-operative pain pathways.
A recent anatomic study from Short et al. demonstrated a greater implication than what was previously known of the accessory obturator nerve and the femoral nerve in the etiology of the post-operative pain. Regarding the incision, it is generally located in the lateral femoral cutaneous nerve territory. Recently published as case reports, the PENG block is a new regional anesthesia technique that has emerged for hip surgeries. It consists of injecting local anesthetics in the myofascial plan between the psoas anteriorly and the pubic ramus posteriorly.
With this prospective randomized trial, the investigators aim to investigate whether a PENG block combined with the LFCN block provides a superior analgesia compared to multimodal analgesia alone and improves the outcomes of the patients in the post-operative phase.
Methods:
The PENG and LFCN blocks will be performed with the patients in a dorsal decubitus position, using a high frequency linear ultrasound probe (Sonosite HFL50 6-15 MHz) in the inguinal area, with an insulated hyperechoic needle (50-80 mm, 22 gauge, Pajunk) placed in plane in relation to the ultrasound beam. The myofascial plane between the psoas anteriorly and the pubic ramus posteriorly will be targeted. The anesthesiologist will confirm the correct position of the needle by injecting 1 ml of 5% dextrose.
For the group A, after negative aspiration, 20 ml of a solution of ropivacaine 0,5% with epinephrine 2,5 mcg/ml will be injected in 5 ml aliquots. Then, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same solution will be injected with the same needle. For group B, the technique of the blocks will be identical to group A, but 20 ml and 5 ml of a sterile saline solution will be used instead.
Patients will then be taken to the operating room where a spinal anesthesia will be performed using 12 mg of iso or hyperbaric bupivacaine (at the discretion of the anesthesiologist) with the addition of 15 mcg of fentanyl. A dose of 8 mg of dexamethasone will be administered intravenously over 10 minutes. In case of failed spinal anesthesia, patient will be excluded from the study.
For hospitalized patients:
In the absence of contraindication, patient controlled analgesia (PCA) with hydromorphone will be prescribed post-operatively, until 8h on post-operative day 1. Patients will thus have the possibility to self-administer 0,2 mg of hydromorphone every 5 minutes, for a maximum of 10 doses per hour. In case of contraindications, subcutaneous or per os hydromorphone will be prescribed to these patients. Multimodal analgesia with acetaminophen and celecoxib (in absence of contraindication) will be continued as per protocol.
For patients treated on an outpatient trajectory:
Patients will benefit from medical prescriptions for total hip replacement, including hydromorphone or oxycodone, celecoxib and acetaminophen.
- Conditions
- Total Hip Replacement Surgery, Postoperative Pain
- Being tested
- Ropivacaine 0.5% Injectable Solution, Saline Solution
- Keywords
- Regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
Also called Ropivacaine 0.5%
ropivacaine 0.5% with epinephrine 2.5 mcg/ml
Saline SolutionDrug
Also called Placebo
normal saline solution (NaCl 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| PENG and LFCN blocks with ropivacaine | Active comparator | For the PENG block, and after negative aspiration, 20 ml of a solution of ropivacaine 0.5% with epinephrine 2.5 mcg/ml will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same solution will be injected with the same needle. Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| PENG and LFCN blocks with saline solution | Placebo comparator | For the PENG block, and after negative aspiration, 20 ml of a saline solution will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same saline solution will be injected with the same needle. Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery, QoR15 (Quality of Recovery 15)
QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).
Measured: Change between baseline (day 0) and post-operative day 1
Secondary outcomes (8)
Verbal numeric rating scale (vNRS) for pain assessment
Postoperative pain assessment will be performed using the vNRS; score (0 = no pain, 10 = unbearable pain). The vNRS scores at rest and after mobilisation (15° hip flexion) will be recorded at postoperative 8, 16 and 24 hours.
Measured: 8 hours, 16 hours and 24 hours after the surgery
Difficulty of realization of the block
Numeric scale from 1 to 5 describing the difficulty of the block based on a local scale that has not been validated. (Score 1= Easy site identification, good needle positioning and adequate dispersion of the solution on the first try; Score 2= Difficulty in identifying the site but positioning and dispersion of the solution on the first try once it has been identified; Score 3= one repositioning of the needle necessary, adequate dispersion thereafter; Score 4= More than one repositioning necessary, adequate dispersion thereafter; Score 5= Dispersion remains suboptimal despite several repositionings of the needle.
Measured: At the end of the blocks on Day 0
Mild cognitive impairment assessment using the Montreal Cognitive Assessment (MoCA)
The incidence of mild cognitive impairment in patients will be evaluated using the MoCA screening validated tool (Score 0-30; higher score indicates better performance) for hospitalized patients.
For patients with an outpatient trajectory, the incidence of mild cognitive impairment in patients will be evaluated using the MoCA BLIND screening validated tool (Score 0-22; higher score indicates better performance). Then the 22-point telephone MoCA will be converted to 30 points for comparison purposes as proposed by Katz et al. 2021
Measured: Pre-operative day 0 (day before or morning of the surgery) and Post-operative day 1
Opioids side effects
The presence or absence of opioids side effects such as drowsiness, desaturation (only for hospitalized patients), nausea and vomiting will be recorded over a 24 hours period after the surgery.
Measured: 8 hours, 16 hours and 24 hours after the surgery
Quadriceps weakness
Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion.
Measured: On post-operative day 1
In-hospital stay for hospitalized patients
Number of days of hospital stay for patients.
Measured: An average of 1 to 2 days
Walking distance after the surgery for hospitalized patients
The walking distance accompanied by a physiotherapist will be recorded.
Measured: On post-operative day 1
Number of participants with block complications
Any complications or side effects of the blocks will be recorded and addressed to insure the safety of the patients, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.
Measured: On post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start4 May 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled, triple blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Garneau, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245280
- Sponsor's protocol ID
- 19.275
- Acronym
- PENG
- Status last verified
- Aug 2024
- First submitted
- 22 Jan 2020
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pericapsular Nerve Group (PENG) Block Combined to Lateral Femoral Cutaneous Nerve (LFCN) Block on the Quality of Recovery After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT04245280
- Acronym / sponsor ID
- PENG / 19.275
- Conditions
- Total Hip Replacement Surgery, Postoperative Pain
- Keywords
- Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Jan 2020 (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.
The main objective of this study is to evaluate the effectiveness of the association of PENG and LFCN blocks on the quality of recovery 24 hours after total hip replacement surgery.
Detailed description
Total hip replacement is a frequent procedure in the geriatric population associated with moderate post-operative pain. It is known that a sub-optimal analgesia is associated with a delayed mobilization leading to a longer hospital stay, poor functional recovery and increased thromboembolic complications. Moreover, opioid analgesia, especially in the geriatric population, increases the incidence of delirium.
Multimodal analgesia, combining different analgesic classes and regional anesthesia, is preferable than relying mainly on opioids, improving the outcomes in the post-operative period. Until now, no regional anesthesia technique has proven itself to be better than the others, each having its limitations. While the local anesthetic doses are high with the peri-articular infiltration under direct visualisation, the epidural is associated with bilateral block and sympathetic block. Also, the lumbar plexus block is a technically difficult block and is associated with a motor block. Finally, other blocks such as the femoral, 3:1 or fascia iliaca are not blocking the totality of the nerves involved in the post-operative pain pathways.
A recent anatomic study from Short et al. demonstrated a greater implication than what was previously known of the accessory obturator nerve and the femoral nerve in the etiology of the post-operative pain. Regarding the incision, it is generally located in the lateral femoral cutaneous nerve territory. Recently published as case reports, the PENG block is a new regional anesthesia technique that has emerged for hip surgeries. It consists of injecting local anesthetics in the myofascial plan between the psoas anteriorly and the pubic ramus posteriorly.
With this prospective randomized trial, the investigators aim to investigate whether a PENG block combined with the LFCN block provides a superior analgesia compared to multimodal analgesia alone and improves the outcomes of the patients in the post-operative phase.
Methods:
The PENG and LFCN blocks will be performed with the patients in a dorsal decubitus position, using a high frequency linear ultrasound probe (Sonosite HFL50 6-15 MHz) in the inguinal area, with an insulated hyperechoic needle (50-80 mm, 22 gauge, Pajunk) placed in plane in relation to the ultrasound beam. The myofascial plane between the psoas anteriorly and the pubic ramus posteriorly will be targeted. The anesthesiologist will confirm the correct position of the needle by injecting 1 ml of 5% dextrose.
For the group A, after negative aspiration, 20 ml of a solution of ropivacaine 0,5% with epinephrine 2,5 mcg/ml will be injected in 5 ml aliquots. Then, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same solution will be injected with the same needle. For group B, the technique of the blocks will be identical to group A, but 20 ml and 5 ml of a sterile saline solution will be used instead.
Patients will then be taken to the operating room where a spinal anesthesia will be performed using 12 mg of iso or hyperbaric bupivacaine (at the discretion of the anesthesiologist) with the addition of 15 mcg of fentanyl. A dose of 8 mg of dexamethasone will be administered intravenously over 10 minutes. In case of failed spinal anesthesia, patient will be excluded from the study.
For hospitalized patients:
In the absence of contraindication, patient controlled analgesia (PCA) with hydromorphone will be prescribed post-operatively, until 8h on post-operative day 1. Patients will thus have the possibility to self-administer 0,2 mg of hydromorphone every 5 minutes, for a maximum of 10 doses per hour. In case of contraindications, subcutaneous or per os hydromorphone will be prescribed to these patients. Multimodal analgesia with acetaminophen and celecoxib (in absence of contraindication) will be continued as per protocol.
For patients treated on an outpatient trajectory:
Patients will benefit from medical prescriptions for total hip replacement, including hydromorphone or oxycodone, celecoxib and acetaminophen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled, triple blind
| Arm | Type | Receives |
|---|---|---|
| PENG and LFCN blocks with ropivacaine | Active comparator | Drug: Ropivacaine 0.5% Injectable SolutionFor the PENG block, and after negative aspiration, 20 ml of a solution of ropivacaine 0.5% with epinephrine 2.5 mcg/ml will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same solution will be injected with the same needle. |
| PENG and LFCN blocks with saline solution | Placebo comparator | Drug: Saline SolutionFor the PENG block, and after negative aspiration, 20 ml of a saline solution will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same saline solution will be injected with the same needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old undergoing a total hip replacement surgery
Key exclusion criteria (6 listed)
- Contraindication to regional anesthesia (allergy to local anesthetics, severe coagulopathy, infection in the designated area, pre-existing neuropathy in the obturator or femoral territory)
- Contraindication to spinal anesthesia
- Patient's refusal or inability to consent
- Opioid use on a regular basis pre-operatively
- Inability to communicate with medical team or research team
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 |
|---|---|---|
| Ropivacaine 0.5% Injectable SolutionAlso: Ropivacaine 0.5%ropivacaine 0.5% with epinephrine 2.5 mcg/ml | Drug | PENG and LFCN blocks with ropivacaine |
| Saline SolutionAlso: Placebonormal saline solution (NaCl 0.9%) | Drug | PENG and LFCN blocks with saline solution |
Primary outcome
Quality of recovery, QoR15 (Quality of Recovery 15)
Time frame: Change between baseline (day 0) and post-operative day 1
QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).
8 secondary outcomes
Verbal numeric rating scale (vNRS) for pain assessment
Time frame: 8 hours, 16 hours and 24 hours after the surgery
Difficulty of realization of the block
Time frame: At the end of the blocks on Day 0
Mild cognitive impairment assessment using the Montreal Cognitive Assessment (MoCA)
Time frame: Pre-operative day 0 (day before or morning of the surgery) and Post-operative day 1
Opioids side effects
Time frame: 8 hours, 16 hours and 24 hours after the surgery
Quadriceps weakness
Time frame: On post-operative day 1
In-hospital stay for hospitalized patients
Time frame: An average of 1 to 2 days
Walking distance after the surgery for hospitalized patients
Time frame: On post-operative day 1
Number of participants with block complications
Time frame: On post-operative day 1
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 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Sébastien Garneau, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.5% Injectable Solution and Saline Solution in people with Total Hip Replacement Surgery and Postoperative Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 1 inclusion and 6 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 6 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.
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?
Quality of recovery, QoR15 (Quality of Recovery 15) (time frame: Change between baseline (day 0) and post-operative day 1). 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 6 Aug 2024.