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Completed

NCT Number: NCT04508504

PENG Block for Arthroscopic Hip Surgery

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.

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Key information

Conditions

Postoperative Pain Hip Arthroscopy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVA Outpatient Surgery Center

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pericapsular nerve group 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.

Ropivacaine 0.5% Injectable Solution

Drug

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

normal saline

Drug

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

Primary outcomes

  1. PACU pain score

    Time frame: 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 outcomes

  1. PACU opioid consumption

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Acronym: PENG

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2020
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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