PENG Block Plus Lateral Femoral Cutaneous Nerve Block for Posterolateral-approached Total Hip Arthroplasty

NCT05432011 | Completed DMC

• 1 other identifier: PAR 34.22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to analyze the effect of Pericapsular Nerve Group (PENG) Block combined with lateral femoral cutaneous nerve block vs. PENG block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach. Half of participants will receive a PENG Block combined with femoral lateral cutaneous nerve block, while the other half will receive PENG Block combined with wound infiltration

Conditions

Pain; Postoperative Pain; Acute Pain; Analgesia; Hip Arthropathy; Postoperative Complications

Outcome Measures

Primary Outcomes (2)

• Static Pain Score

  A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery

  24 hours

• Dynamic Pain Score

  A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain on movement during 24 hours after surgery

  24 hours

Secondary Outcomes (8)

• Morphine consumption

  24 hours

• Morphine consumption

  6 days

• Range of hip motion

  24 hours

• Quadriceps Strength

  24 hours

• Ability to start physiotherapy during the first postoperative day

  24 hours

Study Arms (2)

PENG block plus Femoral Cutaneous Nerve Block

EXPERIMENTAL

Participants receiving PENG block combined to Lateral Femoral Cutaneous Nerve Block

Procedure: PENG Block; Procedure: Lateral Femoral Cutaneous Nerve Block

PENG block plus Wound Infiltration

ACTIVE COMPARATOR

Participants receiving PENG block combined to wound infiltration

Procedure: PENG Block; Procedure: Wound Infiltration

Interventions

PENG Block PROCEDURE

At the end of surgery, in Post Anesthesia Recovery Room (PACU), PENG block with 20 mL of 0.5 % Ropivacaine will be executed as described by Giron-Arango et al. using a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, B.Braun) will be used.

PENG block plus Femoral Cutaneous Nerve Block; PENG block plus Wound Infiltration

Lateral Femoral Cutaneous Nerve Block PROCEDURE

At the end of surgery, in Post Anesthesia Recovery Room (PACU), ultrasound guided Lateral Femoral Cutaneous Nerve Block will be performed with 10 mL of 0.5 % Ropivacaine using a high frequency linear probe. A 22G 50 mm needle (Stimuplex Ultra 360, B.Braun) will be used.

PENG block plus Femoral Cutaneous Nerve Block

Wound Infiltration PROCEDURE

At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine.

PENG block plus Wound Infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective hip replacement surgery performed with a poster-lateral approach
• ASA physical status score \< 4

You may not qualify if:

• Contraindications to regional anesthesia
• ASA physical status score ≥ 4
• Patient's refusal or inability to sign the informed consent
• Allergies to any drug provided by the study protocol

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-medico University Hospital Foundation

Rome, Italy

Location

Related Publications (4)

• Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

  PMID: 34196965 RESULT

• Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.

  PMID: 34290085 RESULT

• 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.

  PMID: 30063657 RESULT

• Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.

  PMID: 33432791 RESULT

MeSH Terms

Conditions

Pain; Pain, Postoperative; Acute Pain; Agnosia; Postoperative Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Giuseppe Pascarella, MD

  University Hospital Campus Biomedico of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 1, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 25, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)