PENG Block Combined to Wound Infiltration for Hip Replacement

NCT ID: NCT04306133

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Analgesia Hip Arthropathy Acute Pain Pain Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PENG BLOCK AND WOUND INFILTRATION

Participants receiving PENG block combined to wound infiltration

Group Type EXPERIMENTAL

PENG block

Intervention Type 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.

Wound Infiltration

Intervention Type PROCEDURE

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

WOUND INFILTRATION

Participants receiving wound infiltration alone

Group Type ACTIVE_COMPARATOR

Wound Infiltration

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Wound Infiltration

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Pascarella

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Pascarella, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Campus Biomedico of Rome

Locations

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Università Campus Biomedico

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 29140962 (View on PubMed)

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.

Reference Type RESULT
PMID: 30063657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34196965 (View on PubMed)

Other Identifiers

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29/20 PAR ComEt CBM

Identifier Type: -

Identifier Source: org_study_id

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