Pericapsular Nerve Group Block for Elective Hip Arthroplasty
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PENG Block with local anesthetic
PENG Block with 0,9% saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Elective Hip Surgery, PENG Block
Eligibility Criteria
Inclusion Criteria:
- Elective total hip arthroplasty
- General anesthesia
- Enhanced Recovery Program
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) Score > 2
- Drug allergy
- Significant psychiatric disturbances
- Preoperative opioid use
- Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
- Body Mass Index > 40 kg/m²
Sites / Locations
- Chu TivoliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PENG group
Placebo group
Arm Description
PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine
PENG block with 20 ml of 0,9% saline
Outcomes
Primary Outcome Measures
Pain Score on first Mobilization
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery
Secondary Outcome Measures
Maximum Pain Score in Post-Anaesthesia Care Unit
Maximum Pain score evaluated in Post Anesthesia Care Unit by a a visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Morphine Consumption at Day 0
Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0
Piritramid Consumption
Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward
Morphine Consumption at Day 1
Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1
Morphine Consumption at Day 2
Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2
Pain Score at Rest 2h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 2h after surgery
Pain Score on mobilization 2h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 2h after surgery
Pain Score at Rest 4h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 4h after surgery
Pain Score on mobilization 4h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 4h after surgery
Pain Score at Rest 6h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 6h after surgery
Pain Score on mobilization 6h Postop
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 6h after surgery
Pain Score at Rest Day 1 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 1
Pain Score on mobilization Day 1 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 1
Pain Score at Rest Day 1 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 1
Pain Score on mobilization Day 1 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 1
Pain Score at Rest Day 2 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 2
Pain Score on mobilization Day 2 AM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 2
Pain Score at Rest Day 2 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 2
Pain Score on mobilization Day 2 PM
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 2
First Mobilization Success
Success rate of patients mobilized the day of surgery
Mean remifentanil Infusion Rate
Total infused remifentanil dose per kg body weight per minute of total operative time
Quadriceps weakness
Evaluation of quadriceps motricity by Neal test which consist in supporting the knee under the popliteal fossa and asking the patient to extend the knee against resistance.
Full Information
NCT ID
NCT04231123
First Posted
January 8, 2020
Last Updated
January 26, 2021
Sponsor
Centre Hospitalier Universitaire de Tivoli
1. Study Identification
Unique Protocol Identification Number
NCT04231123
Brief Title
Pericapsular Nerve Group Block for Elective Hip Arthroplasty
Official Title
Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Tivoli
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
This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.
Detailed Description
Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.
Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.
The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Elective Hip Surgery, PENG Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Injected solutions will be prepared by an anesthetist not involved in the study protocol.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PENG group
Arm Type
Experimental
Arm Description
PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
PENG block with 20 ml of 0,9% saline
Intervention Type
Procedure
Intervention Name(s)
PENG Block with local anesthetic
Intervention Description
After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
Intervention Type
Procedure
Intervention Name(s)
PENG Block with 0,9% saline
Intervention Description
After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
Primary Outcome Measure Information:
Title
Pain Score on first Mobilization
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery
Time Frame
Postoperative time until midnight day 0
Secondary Outcome Measure Information:
Title
Maximum Pain Score in Post-Anaesthesia Care Unit
Description
Maximum Pain score evaluated in Post Anesthesia Care Unit by a a visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Time Frame
Through postoperative time during Post Anesthesia Care Unit stay at day 0
Title
Morphine Consumption at Day 0
Description
Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0
Time Frame
Postoperative time until midnight day 0
Title
Piritramid Consumption
Description
Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward
Time Frame
Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0
Title
Morphine Consumption at Day 1
Description
Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1
Time Frame
Postoperative time during Post Anesthesia Care Unit stay at day 0
Title
Morphine Consumption at Day 2
Description
Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2
Time Frame
Postoperative time until midnight day 2
Title
Pain Score at Rest 2h Postop
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 2h after surgery
Time Frame
2 hours after surgery
Title
Pain Score on mobilization 2h Postop
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 2h after surgery
Time Frame
2 hours after surgery
Title
Pain Score at Rest 4h Postop
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 4h after surgery
Time Frame
4 hours after surgery
Title
Pain Score on mobilization 4h Postop
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 4h after surgery
Time Frame
4 hours after surgery
Title
Pain Score at Rest 6h Postop
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 6h after surgery
Time Frame
6 hours after surgery
Title
Pain Score on mobilization 6h Postop
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 6h after surgery
Time Frame
6 hours after surgery
Title
Pain Score at Rest Day 1 AM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 1
Time Frame
Day 1 in the morning after surgery
Title
Pain Score on mobilization Day 1 AM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 1
Time Frame
Day 1 in the morning after surgery
Title
Pain Score at Rest Day 1 PM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 1
Time Frame
Day 1 in the afternoon after surgery
Title
Pain Score on mobilization Day 1 PM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 1
Time Frame
Day 1 in the afternoon after surgery
Title
Pain Score at Rest Day 2 AM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 2
Time Frame
Day 2 in the morning after surgery
Title
Pain Score on mobilization Day 2 AM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 2
Time Frame
Day 2 in the morning after surgery
Title
Pain Score at Rest Day 2 PM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 2
Time Frame
Day 2 in the afternoon after surgery
Title
Pain Score on mobilization Day 2 PM
Description
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 2
Time Frame
Day 2 in the afternoon after surgery
Title
First Mobilization Success
Description
Success rate of patients mobilized the day of surgery
Time Frame
Postoperative time until midnight day 0
Title
Mean remifentanil Infusion Rate
Description
Total infused remifentanil dose per kg body weight per minute of total operative time
Time Frame
Intraoperatively
Title
Quadriceps weakness
Description
Evaluation of quadriceps motricity by Neal test which consist in supporting the knee under the popliteal fossa and asking the patient to extend the knee against resistance.
Time Frame
Through postoperative time during Post Anesthesia Care Unit stay at day 0
Other Pre-specified Outcome Measures:
Title
Patient satisfaction after 24h
Description
Patient satisfaction for the first 24h after surgery recorded with a scale from 0 (unsatisfied) to 10 (extremely satisfied).
Time Frame
24 hours after surgery
Title
Length of hospital stay
Description
Calculated as the number of days between the hospital admission and discharge dates.
Time Frame
During hospital stay, up to 1 week
Title
PACU stay
Description
Time from the arrival in Post Anesthesia Care Unit until discharge to the ward
Time Frame
Postoperative time during Post Anesthesia Care Unit stay at day 0
Title
Postoperative Nausea and Vomiting
Description
The incidence and severity of postoperative nausea (none=0, mild=1, moderate=2, severe=3), episodes of vomiting, and need for rescue antiemetics was also documented.
Time Frame
PACU, at 2, 6, 24, and 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective total hip arthroplasty
General anesthesia
Enhanced Recovery Program
Exclusion Criteria:
American Society of Anesthesiologists (ASA) Score > 2
Drug allergy
Significant psychiatric disturbances
Preoperative opioid use
Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
Body Mass Index > 40 kg/m²
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Van Rompaey, MD
Phone
+3264276111
Email
nvrompae@chu-tivoli.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Van Rompaey, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Tivoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Tivoli
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Van Rompaey, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
background
Learn more about this trial
Pericapsular Nerve Group Block for Elective Hip Arthroplasty
We'll reach out to this number within 24 hrs