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The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.

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ClinicalTrials.gov Identifier: NCT05056675
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Matthieu Hanauer, Hôpital Fribourgeois

Brief Summary:

Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries.

As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: PENG block Procedure: Placebo Not Applicable

Detailed Description:

Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital.

This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay: A Multidisciplinary Prospective Randomized Double-blind Controlled Trial.
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: PENG block for anterior total hip arthroplasty or surgical hip dislocation
All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of 0.5% ropivacaine iv is injected.
Procedure: PENG block
All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the test item (20 mL of ropivacaine 0.5%, Naropin). The anesthesiologist and the surgeon are blinded to the product injected.

Placebo Comparator: Placebo for anterior total hip arthroplasty or surgical hip dislocation
All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating theatre, routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance, 20 mL of NaCL 0.9% is injected.
Procedure: Placebo
ll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the placebo (20 mL of NaCL 0.9%). The anesthesiologist and the surgeon are blinded to the product injected.




Primary Outcome Measures :
  1. Visual analogue scale (VAS) [ Time Frame: Reduction of postoperative pain in the first 24 hours after surgery ]
    Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity


Secondary Outcome Measures :
  1. Total morphine consumption (morphine equivalent dose) [ Time Frame: Total consumption of postoperative morphine in the first 24 hours after surgery ]
    Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.

  2. Length of stay (days) [ Time Frame: Length of stay at the hospital (in days) from the day of the surgery (day 0) to the day of discharge, up to a maximum of 7 postoperative days ]
    The length of hospital stay is measured in days, from the day of surgery (day 0) to the patient's discharge from the hospital. Discharge occurs up to a maximum of 7 days after surgery when the 3 following criteria are met: the scar must be dry, the pain must no longer require morphine and the patient must be able to walk with crutches



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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anterior total hip arthroplasty for hip osteoarthritis
  • Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer)
  • Age 16-85 years
  • American Society of Anesthesiologists (ASA) physical status 1 to 3

Exclusion Criteria:

  • Patient refusal/no informed consent
  • Inability to give informed consent
  • Lateral approach for total hip arthroplasty
  • Bilateral procedure
  • Additional osteotomies of the femur and/or acetabulum
  • Previous hip & pelvis surgery
  • Chronic opioid users
  • Known allergy or intolerance to medications used in the trial (local anesthetic, opioid)
  • Infection at the injection site
  • Body mass index > 40kg/m2
  • Spinal anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056675


Contacts
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Contact: Matthieu Hanauer, M.D. +41263062810 matthieu.hanauer@h-fr.ch

Locations
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Switzerland
HFR Fribourg - Hôpital cantonal
Fribourg, Switzerland, 1700
Sponsors and Collaborators
Hôpital Fribourgeois
Publications:
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Responsible Party: Matthieu Hanauer, Attending surgeon, M.D., Hôpital Fribourgeois
ClinicalTrials.gov Identifier: NCT05056675    
Other Study ID Numbers: 2021-01792
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD and results of this study will be presented at national and international orthopedic meetings and will be submitted to highly-ranked peer reviewed orthopedic journals.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The study will start in January 2022 and summary data will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthieu Hanauer, Hôpital Fribourgeois:
PENG block
Postoperative pain
Elective hip surgery
Total hip arthroplasty
Surgical hip dislocation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations