Back to resultsCombined PENG and LFCN Block for Total Hip Arthroplasty
Primary Purpose
Anesthesia, Conduction, Pain, Postoperative, Arthroplasty, Replacement, Hip
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PENG + LFCN block
Ropivacaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia, Conduction focused on measuring regional anesthesia, postoperative pain, total hip arthroplasty, pericapsular nerve group block
Eligibility Criteria
Inclusion Criteria:
- adult patients who underwent a primary total hip replacement under general anesthesia
Exclusion Criteria:
- insulin dependent diabetes mellitus
- chronic pain
- severe dementia or mental retardation
- allergy to local anesthetics
Sites / Locations
- AZ Monica
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PENG + LFCN block
No regional anesthesia
Arm Description
The participants in this group received a combined regional technique just before surgery: Pericapsular nerve group (PENG) block Lateral femoral cutaneus nerve (LFCN) block
Control group
Outcomes
Primary Outcome Measures
Initial pain score
numeric rating score (NRS) of 0 to 10
Pain score after 2h
numeric rating score (NRS) of 0 to 10
Pain score after 24h
numeric rating score (NRS) of 0 to 10
Secondary Outcome Measures
Initial motor function
score chart inspired by the Bromage score (NRS) of 0 to 3
Motor function after 2h
score chart inspired by the Bromage score (NRS) of 0 to 3
Motor function after 24h
score chart inspired by the Bromage score (NRS) of 0 to 3
Intraoperative opioids
dose of intravenous opioids in microgram per kilogram bodyweight
Postoperative opioids
dose of intravenous opioids in microgram per kilogram bodyweight
Full Information
NCT ID
NCT04996290
First Posted
July 19, 2021
Last Updated
August 6, 2021
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT04996290
Brief Title
Combined PENG and LFCN Block for Total Hip Arthroplasty
Official Title
Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block for Total Hip Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
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
A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. The results will be compared to a control group that is solely treated with intravenous analgesia. This technique aims to provide improved pain scores after surgery without interference of revalidation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Conduction, Pain, Postoperative, Arthroplasty, Replacement, Hip
Keywords
regional anesthesia, postoperative pain, total hip arthroplasty, pericapsular nerve group block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PENG + LFCN block
Arm Type
Active Comparator
Arm Description
The participants in this group received a combined regional technique just before surgery:
Pericapsular nerve group (PENG) block
Lateral femoral cutaneus nerve (LFCN) block
Arm Title
No regional anesthesia
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Procedure
Intervention Name(s)
PENG + LFCN block
Other Intervention Name(s)
pericapsular nerve group block, lateral femoral cutaneous nerve block
Intervention Description
Regional anesthesia technique
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Other Intervention Name(s)
ropivacaine 0.375%
Intervention Description
Local anesthetic used for peripheral nerve block.
Primary Outcome Measure Information:
Title
Initial pain score
Description
numeric rating score (NRS) of 0 to 10
Time Frame
0 hours postoperative
Title
Pain score after 2h
Description
numeric rating score (NRS) of 0 to 10
Time Frame
2 hours postoperative
Title
Pain score after 24h
Description
numeric rating score (NRS) of 0 to 10
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Initial motor function
Description
score chart inspired by the Bromage score (NRS) of 0 to 3
Time Frame
0 hours postoperative
Title
Motor function after 2h
Description
score chart inspired by the Bromage score (NRS) of 0 to 3
Time Frame
2 hours postoperative
Title
Motor function after 24h
Description
score chart inspired by the Bromage score (NRS) of 0 to 3
Time Frame
24 hours postoperative
Title
Intraoperative opioids
Description
dose of intravenous opioids in microgram per kilogram bodyweight
Time Frame
intraoperative
Title
Postoperative opioids
Description
dose of intravenous opioids in microgram per kilogram bodyweight
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients who underwent a primary total hip replacement under general anesthesia
Exclusion Criteria:
insulin dependent diabetes mellitus
chronic pain
severe dementia or mental retardation
allergy to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yzabel Vandevivere, MD
Organizational Affiliation
AZ Monica
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Monica
City
Deurne
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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
PubMed Identifier
33109730
Citation
Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27. Erratum In: Reg Anesth Pain Med. 2022 May;47(5):e1.
Results Reference
background
PubMed Identifier
31663402
Citation
Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
Results Reference
background
PubMed Identifier
30923252
Citation
Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
Results Reference
background
PubMed Identifier
25599296
Citation
Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.
Results Reference
background
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Combined PENG and LFCN Block for Total Hip Arthroplasty
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