Combined PENG and LFCN Block for Total Hip Arthroplasty

• Sponsor: University Hospital, Antwerp (Other)
• Overall Status: Completed
• CT.gov ID: NCT04996290
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Conduction; Pain, Postoperative; Arthroplasty, Replacement, Hip	Procedure: PENG + LFCN block; Drug: Ropivacaine injection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective randomized controlled trialprospective randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block for Total Hip Arthroplasty: A Randomized Controlled Trial
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PENG + LFCN block The participants in this group received a combined regional technique just before surgery: Pericapsular nerve group (PENG) block Lateral femoral cutaneus nerve (LFCN) block	Procedure: PENG + LFCN block; Regional anesthesia technique; Other Names: pericapsular nerve group block lateral femoral cutaneous nerve block ; Drug: Ropivacaine injection; Local anesthetic used for peripheral nerve block.; Other Names: ropivacaine 0.375%
No Intervention: No regional anesthesia Control group

Outcome Measures

Primary Outcome Measures

1. Initial pain score [0 hours postoperative]

   numeric rating score (NRS) of 0 to 10

2. Pain score after 2h [2 hours postoperative]

   numeric rating score (NRS) of 0 to 10

3. Pain score after 24h [24 hours postoperative]

   numeric rating score (NRS) of 0 to 10

Secondary Outcome Measures

1. Initial motor function [0 hours postoperative]

   score chart inspired by the Bromage score (NRS) of 0 to 3

2. Motor function after 2h [2 hours postoperative]

   score chart inspired by the Bromage score (NRS) of 0 to 3

3. Motor function after 24h [24 hours postoperative]

   score chart inspired by the Bromage score (NRS) of 0 to 3

4. Intraoperative opioids [intraoperative]

   dose of intravenous opioids in microgram per kilogram bodyweight

5. Postoperative opioids [24 hours postoperative]

   dose of intravenous opioids in microgram per kilogram bodyweight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Monica	Deurne		Belgium

Sponsors and Collaborators

• University Hospital, Antwerp

Investigators

• Principal Investigator: Yzabel Vandevivere, MD, AZ Monica

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. 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. pii: rapm-2019-100454. doi: 10.1136/rapm-2019-100454. [Epub ahead of print]
• 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.

• Responsible Party: Lennert De Schrijver, Principal Investigator, University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT04996290
• Other Study ID Numbers: B3002020000032
• First Posted: Aug 9, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lennert De Schrijver, Principal Investigator, University Hospital, Antwerp: regional anesthesia; postoperative pain; total hip arthroplasty; pericapsular nerve group block
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

No Results Posted as of Aug 9, 2021