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NCT Number: NCT04729686

The Pericapsular Nerve Block in Total Hip Arthroplasty

In order to continue progressing towards outpatient total hip arthroplasty (THA), methods to adequately manage postoperative pain is of paramount importance. The purpose of this study is to quantify the effectiveness of the pericapsular nerve block in total hip arthroplasty in comparison to the fascia iliaca nerve block.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location status: Recruiting

Location contact

Ethan Remily, DO

SUB_INVESTIGATOR

James Nace, DO

SUB_INVESTIGATOR

Martin Gesheff

CONTACT

[email protected]

Nirav Patel

CONTACT

[email protected]

Ronald Delanois, MD

PRINCIPAL_INVESTIGATOR

About this study

This is a single center, randomized, controlled trial in adult subjects undergoing total hip arthroplasty that will receive one of two different nerve block regimens for pain management as part of standard of care.

Effective pain control after surgery for total hip replacement is a critical element in patient recovery. Particularly, in the first few days, as majority of patients may experience significant pain. Improved pain management after surgery contributes to better healing, faster patient mobility, shortened hospital stays, and reduced healthcare costs. While pain management is an important factor in total hip replacement, pain after surgery has yet to be improved. Inadequate pain control can lead to delayed movement, thereby increasing the risk for complications such as blood clots in the legs (deep venous thrombosis - blood clots in your veins) with some patients developing blood clots in their lungs (pulmonary embolus). In addition to pain medications after surgery, nerve blocks such as the femoral or fascia iliaca, have been used as supporting therapy for pain management after a total hip replacement. While these nerve blocks are used on a regular basis, they do have limitations which can produce inconsistent results for pain control and use of pain medications after surgery. With no clear superior nerve block for total hip replacement, a new nerve block, called the pericapsular nerve group (PENG) block has emerged. It has demonstrated the ability to prolong pain relief and decrease the use of pain medications after surgery. Therefore, a randomized study comparing the PENG block to other blocks established within the anesthesia community (e.g., fascia iliaca block) will allow for providers to understand the capabilities this block has in the setting of a total hip replacement.

In addition to your normal standard clinical care, there will scheduled pre-operative, operative, 2-week, and 4-6 week follow-up visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Planned primary total hip arthroplasty with anterior (Smith-Peterson) approach
  • ASA score of 1 to 3
  • Indicated for one of the two nerve block groups
  • Must be opioid naïve at screening as defined by the FDA - According to the Food and Drug Administration, opioid-tolerant patients were those currently receiving or who had previously received 60 mg PO morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg PO oxycodone per day, 8 mg PO hydromorphone per day, 25 mg PO oxymorphone per day, 60 mg PO hydrocodone per day, or an equivalent dose of another opioid for a duration of one week or longer (16)

Exclusion criteria

  • Current or previous diagnosis of "chronic pain"
  • Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
  • Diagnosis of ankylosing spondylitis
  • Allergy to any potential medications utilized in any of the two groups
  • Conversion of patient to general anesthesia intraoperatively
  • Treatment with another investigational drug or other intervention for pain
  • Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation

Treatment and study plan

PERICAPSULAR NERVE BLOCK

Drug

Per Standard Institutional Practice

Fascia Iliaca Nerve Block

Drug

Per Standard Institutional Practice

Primary outcomes

  1. Change in Visual Analog Pain Scale (VAS) Score

    Time frame: Every 4 hours from end of surgery to 48 hours post surgery or discharge

    Score recorded by drawing a vertical line on a 100 mm horizontal line between "No Pain" (0 mm) and "Worst Pain" (100 mm)

  2. Postoperative Opioid Consumption in mg

    Time frame: Surgery to 1 month post surgery

    Total opioid consumption will be recorded during postoperative period and at 1 month follow-up visit

Secondary outcomes

  1. Time to first opioid medication

    Time frame: End of surgery 48 hours post-operation or discharge

  2. Time to first ambulation

    Time frame: End of surgery to 48 hours post-operation or discharge

  3. Distance upon first ambulation

    Time frame: 48 hours postoperative or discharge

  4. Incidence of weakness and falls

    Time frame: End of surgery to 48 hours post-operation or discharge

  5. Harris Hip Score

    Time frame: Last preoperative visit to four weeks post-operation

    10 question items measuring pain severity, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing better outcomes.

  6. 12 Item Short Form Health Survey Version 2

    Time frame: Last preoperative visit to four weeks post-operation

    12 question items measuring health and well being as reported by the patient. 2 scores are calculated: 1) Physical Component Summary Score (PCS) and (2) Mental Health Component Summary Score (MCS) in which scores range from 0-100 with a score of zero indicating lowest level of health and 100 indicating the highest level of health.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Gesheff

CONTACT

[email protected]

410-601-9467

Nirav Patel

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

LifeBridge Health

Other

Collaborators

  • Rubin Institute for Advanced Orthopedics

Registry information

Official study title

The Pericapsular Nerve Block in Total Hip Arthroplasty: A Randomized, Controlled Trial

Acronym: PENG

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2021
Registry last updated
Jan 22, 2025

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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