PENG Block for Arthroscopic Hip Surgery

NCT04508504 | Completed

• 1 other identifier: HSR200214
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the analgesic efficacy of the pericapsular nerve group block in the setting of outpatient hip arthroscopy.

Conditions

Postoperative Pain; Hip Arthroscopy

Keywords

pericapsular nerve group block, PENG, hip arthroscopy, pain

Outcome Measures

Primary Outcomes (1)

• PACU pain score

  Maximum pain score within the first 30 minutes after emergence in the post-anesthesia care unit. Pain will be assessed by numerical rating score (0-10, where 0 is no pain, and 10 is the worst possible pain).

  Within 30 minutes of emergence from anesthesia.

Secondary Outcomes (5)

• PACU opioid consumption

  Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).

• Nausea and Vomiting

  Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).

• Patient satisfaction with analgesia

  Determined through follow-up calls at 24 hours and 48-hours.

• Postoperative opioid utilization

  Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively

• Postoperative pain scores

  Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively

Study Arms (2)

Preop PENG Block

EXPERIMENTAL

Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL 0.5% ropivacaine in a manner consistent with Girón-Arango et al 2018 (PMID:30063657). Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (SonoSite S-Nerve or Export) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) is used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After skin localization with 1-2 mL 1% lidocaine, a 22g 80 mm echogenic block needle (Pajunk SonoBlock II Facet) is advanced lateral to medial, in plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence, in 5 mL increments with periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site wiped clean.

Procedure: Preop PENG block; Drug: Ropivacaine 0.5% Injectable Solution

Placebo

PLACEBO COMPARATOR

Patients in the placebo group will receive a subcutaneous injection of 5 mL 0.9% normal saline. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (SonoSite S-Nerve or Export) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) is used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After skin localization with 1-2 mL 1% lidocaine, a 22g 80 mm echogenic block needle (Pajunk SonoBlock II Facet) is advanced lateral to medial, in plane with the ultrasound beam, 1-2 cm beneath the skin, remaining in the subcutaneous tissue. 5 mL of 0.9% normal saline is injected, with periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site wiped clean.

Procedure: Placebo block; Drug: Normal Saline

Interventions

Preop PENG block PROCEDURE

Ultrasound-guided injection of 20 mL 0.5% ropivacaine according to the method described by Giron-Arango L in 2018. A needle is inserted at the inguinal level under ultrasound guidance to pass beneath the psoas tendon on top of the iliopubic eminence where the local anesthetic is injected.

Also known as: Pericapsular nerve group block

Preop PENG Block

Placebo block PROCEDURE

Ultrasound-guided placebo injection of 5 mL 0.9% normal saline. Using the same landmarks as for the PENG group, a needle is inserted in the inguinal region under ultrasound guidance, whereby a subcutaneous injection of 5 mL of 0.9% saline is made.

Placebo

Ropivacaine 0.5% Injectable Solution DRUG

20 mL 0.5% ropivacaine will be injected for the preop PENG block

Preop PENG Block

Normal Saline DRUG

5 mL 0.9% Normal saline will be injected for the Placebo block

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old undergoing unilateral hip arthroscopy at the outpatient surgery center.

You may not qualify if:

• refusal to participate
• \< 18 yo
• Chronic opioid use
• localized infection

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Outpatient Surgery Center

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

• 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 BACKGROUND

• Amato PE, Coleman JR, Dobrzanski TP, Elmer DA, Gwathmey FW Jr, Slee AE, Hanson NA. Pericapsular nerve group (PENG) block for hip arthroscopy: a randomized, double-blinded, placebo-controlled trial. Reg Anesth Pain Med. 2022 Aug 23:rapm-2022-103907. doi: 10.1136/rapm-2022-103907. Online ahead of print.

  PMID: 35998937 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Peter E Amato, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized to one of two groups with a computer generated arm assignment. The sealed envelopes will be opened immediately prior to nerve block. One group will receive a PENG block and the other will receive a placebo block. The provider performing the block will not be blinded, however all other members of the care team, the patient, and the investigator collecting data will be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: Randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 11, 2020
• Study Start: December 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 8, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)