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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04996290
Other study ID # B3002020000032
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date October 1, 2020

Study information

Verified date August 2021
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 1, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Procedure:
PENG + LFCN block
Regional anesthesia technique
Drug:
Ropivacaine injection
Local anesthetic used for peripheral nerve block.

Locations

Country Name City State
Belgium AZ Monica Deurne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

Girón-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. — View Citation

Højer 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. Review. — View 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. Review. — View 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. pii: rapm-2019-100454. doi: 10.1136/rapm-2019-100454. [Epub ahead of print] — View 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(®)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30. Review. Update in: Acta Orthop. 2020 Feb 14;:1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Initial pain score numeric rating score (NRS) of 0 to 10 0 hours postoperative
Primary Pain score after 2h numeric rating score (NRS) of 0 to 10 2 hours postoperative
Primary Pain score after 24h numeric rating score (NRS) of 0 to 10 24 hours postoperative
Secondary Initial motor function score chart inspired by the Bromage score (NRS) of 0 to 3 0 hours postoperative
Secondary Motor function after 2h score chart inspired by the Bromage score (NRS) of 0 to 3 2 hours postoperative
Secondary Motor function after 24h score chart inspired by the Bromage score (NRS) of 0 to 3 24 hours postoperative
Secondary Intraoperative opioids dose of intravenous opioids in microgram per kilogram bodyweight intraoperative
Secondary Postoperative opioids dose of intravenous opioids in microgram per kilogram bodyweight 24 hours postoperative
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