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Effectiveness of PENG Block Combined to LFCN Block on the Quality of Recovery After Total Hip Replacement (PENG)

Primary Purpose

Total Hip Replacement Surgery, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Saline Solution
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Hip Replacement Surgery focused on measuring Regional anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 18 years old undergoing a total hip replacement surgery

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PENG and LFCN blocks with ropivacaine

PENG and LFCN blocks with saline solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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).
Opioids side effects
The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting will be recorded over a 24 hours period 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.
In-hospital stay
Number of days of hospital stay for patients.
Walking distance after the surgery
The walking distance accompanied by a physiotherapist will be recorded.
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.

Full Information

First Posted
January 22, 2020
Last Updated
February 23, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04245280
Brief Title
Effectiveness of PENG Block Combined to LFCN Block on the Quality of Recovery After Total Hip Replacement
Acronym
PENG
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

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

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Replacement Surgery, Postoperative Pain
Keywords
Regional anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled, triple blind
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
triple blind
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG and LFCN blocks with ropivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PENG and LFCN blocks with saline solution
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
Ropivacaine 0.5%
Intervention Description
ropivacaine 0.5% with epinephrine 2.5 mcg/ml
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
Placebo
Intervention Description
normal saline solution (NaCl 0.9%)
Primary Outcome Measure Information:
Title
Quality of recovery, QoR15 (Quality of Recovery 15)
Description
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).
Time Frame
Change between baseline (day 0) and post-operative day 1
Secondary Outcome Measure Information:
Title
Verbal numeric rating scale (vNRS) for pain assessment
Description
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.
Time Frame
8 hours, 16 hours and 24 hours after the surgery
Title
Difficulty of realization of the block
Description
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.
Time Frame
At the end of the blocks on Day 0
Title
Mild cognitive impairment assessment using the Montreal Cognitive Assessment (MoCA)
Description
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).
Time Frame
Pre-operative day 0 (morning of the surgery) and Post-operative day 1
Title
Opioids side effects
Description
The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting will be recorded over a 24 hours period after the surgery.
Time Frame
8 hours, 16 hours and 24 hours after the surgery
Title
Quadriceps weakness
Description
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.
Time Frame
On post-operative day 1
Title
In-hospital stay
Description
Number of days of hospital stay for patients.
Time Frame
An average of 1 to 2 days
Title
Walking distance after the surgery
Description
The walking distance accompanied by a physiotherapist will be recorded.
Time Frame
On post-operative day 1
Title
Number of participants with block complications
Description
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.
Time Frame
On post-operative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years old undergoing a total hip replacement surgery Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Garneau, MD, FRCPC
Phone
514-890-8000
Ext
12131
Email
sebastien.garneau@videotron.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Desroches, PhD
Phone
5148908000
Ext
24542
Email
anesthesie.recherche.chum@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Garneau, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicky Thiffault, RN, CCRP
Phone
514-890-8000
Ext
20113
Email
anesthesie.recherche.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Julie Desroches, PhD
Phone
514-890-8000
Ext
12172
Email
anesthesie.recherche.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Sébastien Garneau, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Stephan Williams, MD, PhD
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Maxim Roy, MD, FRCPC

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of PENG Block Combined to LFCN Block on the Quality of Recovery After Total Hip Replacement

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