Clinical trial NCT06075004: Total Periarticular Infiltration Vs Posterior Periarticular Infiltration Plus PENG Block for Hip Analgesia
Official title: A Randomized Comparison Between Total Periarticular Anesthetic Infiltration and Partial Posterior Periarticular Anesthetic Infiltration Plus Low Volume Ultrasound-Guided Pericapsular Nerve Group Block for Total Hip Replacement Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Postoperative Pain
Keywords: Nerve block
Periarticular infiltration
Hip replacement
Early rehabilitation
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized comparison between two analgesic techniques
Primary purpose: TREATMENT

Brief summary: In a recent study, direct periarticular local anesthetic infiltration (PAI) showed a greater incidence of early quadriceps weakness (33% at 3 hours and 13% at 6 hours) than pericapsular nerve group block (PENGB) in total hip arthroplasty (THA) but, in turn, demonstrated a statistically significant better pain control. Additionally, PENGB could not completely circumvent motor compromise either, particularly at 3 hours (20% incidence), probably secondary to an injectate migration towards the femoral nerve. Posteriorly to this publication, a cadaveric trial looking into the maximum effective volume that spared the femoral nerve resulted in 13.2 mL.

This newer evidence led to the design of a strategy that combines both interventions, aiming to obtain the best of them and have a solid alternative for those cases where very early mobilization is pursued.

Thus, it is hypothesized that posterior PAI added to a low-volume PENGB (10mL) represents a superior alternative to PAI in terms of strength preservation and provides effective analgesia during the first 24 postoperative hours after THA.

Detailed description: Patients who agree to participate in the protocol will be assigned to one group or another (PAI or posterior PAI+PENGB) through computationally generated block randomization. Outcome assessors blinded to randomization will perform all measurements.

All trial interventions (PAI or posterior PAI+PENGB) will be performed (or supervised) by one of the co-authors, an expert orthopedic surgeon anesthesiologist. Both interventions will be executed in the operating room, on the surgical table, under sedation, and with the barrier that separates the surgical field from the cranial area of the patient to keep the latter blind to the technique received.

All patients will undergo spinal anesthesia using 0.5% bupivacaine (10mg) plus 20 μg of fentanyl. Both groups will also receive tranexamic acid 1g intravenous (IV), ketoprofen 100mg IV, and acetaminophen 1gr IV. Propofol sedation guided with a targeted controlled infusion (TCI) model will be administered in order to obtain an adequate level of sedation.

All surgeries will be conducted by the same team of surgeons, performing a posterior approach technique in the lateral decubitus position.

In the recovery room, all patients will receive patient-controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (1 g per os every 6 hours), ketoprofen (100 mg per os every 8 hours) as well and patient-controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs) or morphine
* Pregnancy
* Prior surgery in the inguinal area corresponding surgical side
* Chronic pain syndromes requiring opioid intake at home

Primary outcomes:
measure: Presence of quadriceps motor block (defined as paralysis or paresis)
timeFrame: 3 hours after post anesthesia care unit (PACU) arrival
Secondary outcomes:
measure: Presence of quadriceps motor block (defined as paralysis or paresis)
timeFrame: 6 hours after post anesthesia care unit (PACU) arrival
measure: Presence of quadriceps motor block (defined as paralysis or paresis)
timeFrame: 24 hours after post anesthesia care unit (PACU) arrival
measure: Hip adduction strength
timeFrame: 3 hours after post anesthesia care unit (PACU) arrival
measure: Hip adduction strength
timeFrame: 6 hours after post anesthesia care unit (PACU) arrival
measure: Hip adduction strength
timeFrame: 24 hours after post anesthesia care unit (PACU) arrival
measure: Postoperative morphine consumption
timeFrame: 24 hours after PACU arrival
measure: Postoperative morphine consumption
timeFrame: 48 hours after PACU arrival
measure: Time until first morphine demand
timeFrame: 48 hours after PACU arrival
measure: Static and dynamic pain
timeFrame: 3 hours after PACU arrival
measure: Static and dynamic pain
timeFrame: 6 hours after PACU arrival
measure: Static and dynamic pain
timeFrame: 12 hours after PACU arrival
measure: Static and dynamic pain
timeFrame: 18 hours after PACU arrival
measure: Static and dynamic pain
timeFrame: 24 hours after PACU arrival
measure: Static and dynamic pain
timeFrame: 48 hours after PACU arrival
measure: Sensory block
timeFrame: 3 hours after PACU arrival
measure: Sensory block
timeFrame: 6 hours after PACU arrival
measure: Sensory block
timeFrame: 24 hours after PACU arrival
measure: Block/Infiltration-related complications
timeFrame: 1 hour after nerve block or local anesthetic infiltration
measure: Postoperative opioid related side effects
timeFrame: 48 hours after PACU arrival
measure: Duration of surgery
timeFrame: 4 hours after skin incision
measure: Inability to perform physiotherapy due to motor block
timeFrame: 6 hours after PACU arrival
measure: Inability to perform physiotherapy due to motor block
timeFrame: Postoperative day 1
measure: Inability to perform physiotherapy due to motor block
timeFrame: Postoperative day 2
measure: Inability to perform physiotherapy due to pain
timeFrame: 6 hours after PACU arrival
measure: Inability to perform physiotherapy due to pain
timeFrame: Postoperative day 1
measure: Inability to perform physiotherapy due to pain
timeFrame: Postoperative day 2
measure: Readiness to discharge
timeFrame: 4 days after surgery
measure: Length of hospital stay
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitana
Study officials:
affiliation: University of Chile
name: Daniela Bravo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
citation: Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
citation: 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.
citation: Kuchalik J, Magnuson A, Lundin A, Gupta A. Local infiltration analgesia or femoral nerve block for postoperative pain management in patients undergoing total hip arthroplasty. A randomized, double-blind study. Scand J Pain. 2017 Jul;16:223-230. doi: 10.1016/j.sjpain.2017.05.002. Epub 2017 Jun 1.
citation: Bravo D, Aliste J, Layera S, Fernandez D, Erpel H, Aguilera G, Arancibia H, Barrientos C, Wulf R, Leon S, Branes J, Finlayson RJ, Tran Q. Randomized clinical trial comparing pericapsular nerve group (PENG) block and periarticular local anesthetic infiltration for total hip arthroplasty. Reg Anesth Pain Med. 2023 Oct;48(10):520-521. doi: 10.1136/rapm-2023-104487. Epub 2023 Mar 22. No abstract available.
citation: Leurcharusmee P, Kantakam P, Intasuwan P, Malatong Y, Maikong N, Navic P, Kitcharanant N, Mahakkanukrauh P, Tran Q. Cadaveric study investigating the femoral nerve-sparing volume for pericapsular nerve group (PENG) block. Reg Anesth Pain Med. 2023 Nov;48(11):549-552. doi: 10.1136/rapm-2023-104419. Epub 2023 Apr 7.