PENG Block for Arthroscopic Hip Surgery (PENG)

Pericapsular Nerve Group (PENG) Block for Arthroscopic Hip Surgery: A Randomized, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hip Arthroscopy
• Intervention / Treatment: Procedure: Preop PENG block; Drug: Ropivacaine 0.5% Injectable Solution; Procedure: Placebo block; Drug: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Outpatient Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Other Names: Pericapsular nerve group block; Drug: Ropivacaine 0.5% Injectable Solution; 20 mL 0.5% ropivacaine will be injected for the preop PENG block
Placebo Comparator: 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.	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.; Drug: Normal Saline; 5 mL 0.9% Normal saline will be injected for the Placebo block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU opioid consumption	Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.	Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).
Nausea and Vomiting	This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.	Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).
Patient satisfaction with analgesia	Patients will be called at 24 hours and 48 hours postoperatively. They will be asked during each call if they are satisfied with their pain control (binary - yes or no).	Determined through follow-up calls at 24 hours and 48-hours.
Postoperative opioid utilization	Cumulative postoperative opioid consumption expressed in morphine milligram equivalents	Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively
Postoperative pain scores	Postoperative numerical rating scores after discharge (0-10, where 0 is no pain, and 10 is the worst possible pain).	Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Peter E Amato, MD, University of Virginia

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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: August 8, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pericapsular nerve group block, PENG, hip arthroscopy, pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: HSR200214

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