PENG Block Combined to Wound Infiltration for Hip Replacement

Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial

This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.

Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative Complications; Postoperative Pain; Analgesia; Acute Pain; Hip Arthropathy
• Intervention / Treatment: Procedure: PENG block; Procedure: Wound Infiltration

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Università Campus Biomedico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective hip replacement surgery
• ASA physical status score < 4

Exclusion Criteria:

• Contraindications to regional anesthesia
• ASA physical status score ≥ 4
• Patient's refusal or inability to sing the informed consent
• Pre-operatively therapy with opioids
• Allergies to any drug provided by the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG BLOCK AND WOUND INFILTRATION; Participants receiving PENG block combined to wound infiltration	Procedure: PENG block; After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.; Procedure: Wound Infiltration; At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.
Active Comparator: WOUND INFILTRATION; Participants receiving wound infiltration alone	Procedure: Wound Infiltration; At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Pain Score	A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain during 48 h after surgery	24 hours
Total opioids consumption	Total of Sublingual Sufentanil tablets released	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first opioid	Time (hours) from the end of surgery to the first opioid administration	48 hours
Range of hip motion	Degrees of hip flexion	24 hours
Time to ambulation	Time until the patient is able to stand up and walk with or without assistive devices	48 hours
Quadriceps weakness	Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion	48 hours
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.	48 hours
Opioids side effects	The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting	48 hours

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Giuseppe Pascarella, MD, University Hospital Campus Biomedico of Rome

Publications and helpful links

General Publications

• 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.
• Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.
• Pascarella G, Costa F, Del Buono R, Pulitanò R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agrò 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PENG; regional anesthesia; hip surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Acute Pain; Postoperative Complications
• Other Study ID Numbers: 29/20 PAR ComEt CBM

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