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

Pain Clinical Trial

— PENG-FLAT  

Official title:

PENG Block Combined to Lateral Femoral Cutaneous Nerve Block vs. PENG Block Combined to Wound Infiltration for Postoperative Analgesia Following Posterolateral-approached Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432011
• Other study ID #: PAR 34.22
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: August 2023
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 25, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective hip replacement surgery performed with a poster-lateral approach

• ASA physical status score < 4

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Hip Arthropathy
• Pain
• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• PENG Block
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.
• Lateral Femoral Cutaneous Nerve Block
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.
• Wound Infiltration
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.5 % Ropivacaine.

Locations

Country	Name	City	State
Italy	Campus Bio-medico University Hospital Foundation	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View 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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Morphine consumption	Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery	24 hours
Secondary	Morphine consumption	Total of intravenous morphine (expressed in milligrams) administered during the entire hospitalization	6 days
Secondary	Range of hip motion	Degrees of hip flexion	24 hours
Secondary	Quadriceps Strength	Ability to flex the knee against gravity	24 hours
Secondary	Ability to start physiotherapy during the first postoperative day	YES: the patient was able to start physiotherapy NO: the patient was not able to start physiotherapy during the first postoperative day due to pain or motor block	24 hours
Secondary	Ability to ambulate with the help of a walker during the first postoperative day	YES: The patient was able to ambulate with the help of a walker NO: The patient was not able to ambulate with the help of a walker due to pain or motor block	24 hours
Secondary	Incidence of block complications	Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.; Moreover, incidence of nausea, vomiting and postoperative respiratory depression will be recorded	24 hours
Secondary	Hospital Length of Stay	Total Hospital length of Stay (expressed in days)	6 days