- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04996290
Combined PENG and LFCN Block for Total Hip Arthroplasty
August 6, 2021 updated by: Lennert De Schrijver, University Hospital, Antwerp
Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block for Total Hip Arthroplasty: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Deurne, Belgium
- AZ Monica
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PENG + LFCN block
The participants in this group received a combined regional technique just before surgery:
|
Regional anesthesia technique
Other Names:
Local anesthetic used for peripheral nerve block.
Other Names:
|
No Intervention: No regional anesthesia
Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial pain score
Time Frame: 0 hours postoperative
|
numeric rating score (NRS) of 0 to 10
|
0 hours postoperative
|
Pain score after 2h
Time Frame: 2 hours postoperative
|
numeric rating score (NRS) of 0 to 10
|
2 hours postoperative
|
Pain score after 24h
Time Frame: 24 hours postoperative
|
numeric rating score (NRS) of 0 to 10
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial motor function
Time Frame: 0 hours postoperative
|
score chart inspired by the Bromage score (NRS) of 0 to 3
|
0 hours postoperative
|
Motor function after 2h
Time Frame: 2 hours postoperative
|
score chart inspired by the Bromage score (NRS) of 0 to 3
|
2 hours postoperative
|
Motor function after 24h
Time Frame: 24 hours postoperative
|
score chart inspired by the Bromage score (NRS) of 0 to 3
|
24 hours postoperative
|
Intraoperative opioids
Time Frame: intraoperative
|
dose of intravenous opioids in microgram per kilogram bodyweight
|
intraoperative
|
Postoperative opioids
Time Frame: 24 hours postoperative
|
dose of intravenous opioids in microgram per kilogram bodyweight
|
24 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yzabel Vandevivere, MD, AZ Monica
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
July 19, 2021
First Submitted That Met QC Criteria
August 6, 2021
First Posted (Actual)
August 9, 2021
Study Record Updates
Last Update Posted (Actual)
August 9, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3002020000032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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