PENG Block for Arthroscopic Hip Surgery

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT04508504
Collaborator
(none)
70
1
2
14.3
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Preop PENG block
  • Procedure: Placebo block
  • Drug: Ropivacaine 0.5% Injectable Solution
  • Drug: Normal Saline
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double blind, placebo controlledRandomized, double blind, placebo controlled
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Pericapsular Nerve Group (PENG) Block for Arthroscopic Hip Surgery: A Randomized, Placebo-controlled Trial
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 8, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. PACU pain score [Within 30 minutes of emergence from anesthesia.]

      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).

    Secondary Outcome Measures

    1. PACU opioid consumption [Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).]

      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.

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

      This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.

    3. Patient satisfaction with analgesia [Determined through follow-up calls at 24 hours and 48-hours.]

      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).

    4. Postoperative opioid utilization [Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively]

      Cumulative postoperative opioid consumption expressed in morphine milligram equivalents

    5. Postoperative pain scores [Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively]

      Postoperative numerical rating scores after discharge (0-10, where 0 is no pain, and 10 is the worst possible pain).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UVA Outpatient Surgery Center Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • University of Virginia

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Peter Amato, MD, Assistant Professor of Anesthesiology, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT04508504
    Other Study ID Numbers:
    • HSR200214
    First Posted:
    Aug 11, 2020
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peter Amato, MD, Assistant Professor of Anesthesiology, University of Virginia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 25, 2022