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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: PENG block; Procedure: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Fribourg, Switzerland, 1700
    • HFR Fribourg - Hôpital Cantonal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS)	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	Reduction of postoperative pain in the first 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption (morphine equivalent dose)	Total morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.	Total consumption of postoperative morphine in the first 24 hours after surgery
Length of stay (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	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

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois
• Investigators: Principal Investigator: Matthieu Hanauer, M.D., HFR Fribourg - Hôpital Cantonal

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.
• Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
• Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
• Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
• Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
• Cuschieri S. The CONSORT statement. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S27-S30. doi: 10.4103/sja.SJA_559_18.
• Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013 Jan 21;346:e8668. doi: 10.1136/bmj.e8668.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 28, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Postoperative pain; PENG block; Elective hip surgery; Surgical hip dislocation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2021-01792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: The study will start in June 2022 and summary data will be published.
• IPD Sharing Access Criteria: Publication in progress
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No