PENG Block for Arthroscopic Hip Surgery

NCT ID: NCT04508504

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-02-08

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.

Detailed Description

The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. The analgesic value of this block in the setting of hip arthroscopy is unknown. This study aims to compare a preoperative PENG block to placebo block prior to outpatient hip arthroscopy under general anesthesia. The primary outcome measure is immediate postoperative pain as measured by numerical rating score in the post-anesthesia care unit (PACU). Secondary outcomes include opioid consumption, opioid-related adverse events, patient satisfaction, chronic opioid usage, and pain scores at other time points.

Conditions

Postoperative Pain; Hip Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Preop PENG Block

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 The needle is withdrawn, and the needle entry site wiped clean.

Group Type: EXPERIMENTAL

Preop PENG block

Intervention Type: 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.

Ropivacaine 0.5% Injectable Solution

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo block

Intervention Type: 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.

Normal Saline

Intervention Type: DRUG

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

Interventions

Preop PENG block

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.

Intervention Type: PROCEDURE

Placebo block

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.

Intervention Type: PROCEDURE

Ropivacaine 0.5% Injectable Solution

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

Intervention Type: DRUG

Normal Saline

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

Intervention Type: DRUG

Other Intervention Names

Pericapsular nerve group block

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Peter Amato, MD

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter E Amato, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

UVA Outpatient Surgery Center

Charlottesville, Virginia, United States

Countries

United States

References

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: BACKGROUND

PMID: 30063657 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35998937 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HSR200214

Identifier Type: -

Identifier Source: org_study_id