PENG Block Combined to Wound Infiltration for Hip Replacement

NCT04306133 | Completed DMC

• 1 other identifier: 29/20 PAR ComEt CBM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

regional anesthesia; hip surgery; PENG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Time to first opioid

  48 hours

• Range of hip motion

  24 hours

• Time to ambulation

  48 hours

• Quadriceps weakness

  48 hours

• Incidence of block complications

  48 hours

Study Arms (2)

PENG BLOCK AND WOUND INFILTRATION

EXPERIMENTAL

Participants receiving PENG block combined to wound infiltration

Procedure: PENG block; Procedure: Wound Infiltration

WOUND INFILTRATION

ACTIVE COMPARATOR

Participants receiving wound infiltration alone

Procedure: Wound Infiltration

Interventions

PENG block PROCEDURE

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.

PENG BLOCK AND WOUND INFILTRATION

Wound Infiltration PROCEDURE

At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.

PENG BLOCK AND WOUND INFILTRATION; 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
• 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 sing the informed consent
• Pre-operatively therapy with opioids
• Allergies to any drug provided by the study protocol

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Università Campus Biomedico

Roma, Italy

Location

Related Publications (3)

• 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.

  PMID: 29140962 BACKGROUND

• 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

• 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 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; 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: March 8, 2020
• First Posted: March 12, 2020
• Study Start: March 9, 2020
• Primary Completion: December 24, 2020
• Study Completion: December 31, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)