Total Periarticular Infiltration Vs Posterior Periarticular Infiltration Plus PENG Block for Hip Analgesia

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075004
• Other study ID #: OAIC 1379/23
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: October 2023
• Source: University of Chile
• Contact: Daniela Bravo, MD
• Phone: 569222878209
• Email: dbravoadvis[@]uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 23, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip
• Postoperative Pain

Intervention

Procedure:
• Periarticular Local Anesthetic Infiltration
Sixty milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg will be deposited by the orthopedic surgeon at the periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure.
• Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block
From a total of forty-five milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg, 15mL will be deposited by the orthopedic surgeon at the posterior periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure with the remaining 30mL. After wound closure, an ultrasound-guided pericapsular nerve group block will be performed by an anesthesiologist by injecting 10mL of 0.5% bupivacaine + 5ug/mL epinephrine in the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of quadriceps motor block (defined as paralysis or paresis)	Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. The subject will be asked to extend the knee, first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	3 hours after post anesthesia care unit (PACU) arrival
Secondary	Presence of quadriceps motor block (defined as paralysis or paresis)	Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. The subject will be asked to extend the knee, first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	6 hours after post anesthesia care unit (PACU) arrival
Secondary	Presence of quadriceps motor block (defined as paralysis or paresis)	Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. The subject will be asked to extend the knee, first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	24 hours after post anesthesia care unit (PACU) arrival
Secondary	Hip adduction strength	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1, and 2 points as decreases in strength of 0-20% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively.	3 hours after post anesthesia care unit (PACU) arrival
Secondary	Hip adduction strength	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1, and 2 points as decreases in strength of 0-20% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively.	6 hours after post anesthesia care unit (PACU) arrival
Secondary	Hip adduction strength	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1, and 2 points as decreases in strength of 0-20% (normal strength), 21-70% (paresis), and 71-90% (paralysis) compared to the baseline measurement, respectively.	24 hours after post anesthesia care unit (PACU) arrival
Secondary	Postoperative morphine consumption	Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.	24 hours after PACU arrival
Secondary	Postoperative morphine consumption	Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.	48 hours after PACU arrival
Secondary	Time until first morphine demand	Time (minutes) until first patient-controlled analgesia morphine demand.	48 hours after PACU arrival
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain).	3 hours after PACU arrival
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain).	6 hours after PACU arrival
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain).	12 hours after PACU arrival
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain).	18 hours after PACU arrival
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain).	24 hours after PACU arrival
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement (hip adduction) using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain).	48 hours after PACU arrival
Secondary	Sensory block	Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch).	3 hours after PACU arrival
Secondary	Sensory block	Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch).	6 hours after PACU arrival
Secondary	Sensory block	Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch).	24 hours after PACU arrival
Secondary	Block/Infiltration-related complications	Incidence of adverse events related to nerve block or local anesthetic infiltration (i.e. vascular puncture, local anesthetic systemic toxicity).	1 hour after nerve block or local anesthetic infiltration
Secondary	Postoperative opioid related side effects	Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.	48 hours after PACU arrival
Secondary	Duration of surgery	Time between skin incision and closure (min).	4 hours after skin incision
Secondary	Inability to perform physiotherapy due to motor block	Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to decreased strength in the operated limb.	6 hours after PACU arrival
Secondary	Inability to perform physiotherapy due to motor block	Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to decreased strength in the operated limb.	Postoperative day 1
Secondary	Inability to perform physiotherapy due to motor block	Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to decreased strength in the operated limb.	Postoperative day 2
Secondary	Inability to perform physiotherapy due to pain	Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.	6 hours after PACU arrival
Secondary	Inability to perform physiotherapy due to pain	Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.	Postoperative day 1
Secondary	Inability to perform physiotherapy due to pain	Number of participants that cannot end the physiotherapy protocol programmed for the sixth hour after PACU arrival secondary to pain in the operated limb.	Postoperative day 2
Secondary	Readiness to discharge	Days to be ready for discharge following physiotherapist criteria	4 days after surgery
Secondary	Length of hospital stay	Length of hospital stay after surgery	7 days after surgery