Hip OsteoarthritisNCT06075004
Total Periarticular Infiltration Vs Posterior Periarticular Infiltration Plus PENG Block for Hip Analgesia
A study testing Periarticular Local Anesthetic Infiltration and Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block in people with Hip Osteoarthritis and Postoperative Pain, run by University of Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Postoperative Pain
- What is being tested?
- Periarticular Local Anesthetic Infiltration and Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChile
- Study dates
- 18 Oct 2023to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Prior surgery in the inguinal area corresponding surgical side
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
Daniela B Advis, +56984276252, dbravoadvis@uchile.cl
About this study
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
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.
Read the 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).
- Conditions
- Hip Osteoarthritis, Postoperative Pain
- Being tested
- Periarticular Local Anesthetic Infiltration, Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block
- Keywords
- Nerve block, Periarticular infiltration, Hip replacement, Early rehabilitation
- Medical subject headings
- Osteoarthritis, Hip, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular Local Anesthetic InfiltrationProcedure or surgery
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 BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular Local Anesthetic Infiltration | Active comparator | 60 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the periarticular level before wound closure. Receives: Procedure: Periarticular Local Anesthetic Infiltration |
| Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block | Experimental | 45 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the posterior periarticular level before wound closure.
After wound closure, an ultrasound-guided pericapsular nerve group block of the hip will be performed using ten mL of 0.5% bupivacaine with 5ug/mL epinephrine. Receives: Procedure: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 hours after post anesthesia care unit (PACU) arrival
Secondary outcomes (28)
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).
Measured: 6 hours after post anesthesia care unit (PACU) arrival
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).
Measured: 24 hours after post anesthesia care unit (PACU) arrival
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.
Measured: 3 hours after post anesthesia care unit (PACU) arrival
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.
Measured: 6 hours after post anesthesia care unit (PACU) arrival
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.
Measured: 24 hours after post anesthesia care unit (PACU) arrival
Postoperative morphine consumption
Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Measured: 24 hours after PACU arrival
Postoperative morphine consumption
Consumption of intravenous morphine (mg) registered by a patient-controlled analgesia device.
Measured: 48 hours after PACU arrival
Time until first morphine demand
Time (minutes) until first patient-controlled analgesia morphine demand.
Measured: 48 hours after PACU arrival
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).
Measured: 3 hours after PACU arrival
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).
Measured: 6 hours after PACU arrival
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).
Measured: 12 hours after PACU arrival
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).
Measured: 18 hours after PACU arrival
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).
Measured: 24 hours after PACU arrival
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).
Measured: 48 hours after PACU arrival
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).
Measured: 3 hours after PACU arrival
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).
Measured: 6 hours after PACU arrival
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).
Measured: 24 hours after PACU arrival
Block/Infiltration-related complications
Incidence of adverse events related to nerve block or local anesthetic infiltration (i.e. vascular puncture, local anesthetic systemic toxicity).
Measured: 1 hour after nerve block or local anesthetic infiltration
Postoperative opioid related side effects
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.
Measured: 48 hours after PACU arrival
Duration of surgery
Time between skin incision and closure (min).
Measured: 4 hours after skin incision
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.
Measured: 6 hours after PACU arrival
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.
Measured: Postoperative day 1
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.
Measured: Postoperative day 2
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.
Measured: 6 hours after PACU arrival
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.
Measured: Postoperative day 1
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.
Measured: Postoperative day 2
Readiness to discharge
Days to be ready for discharge following physiotherapist criteria
Measured: 4 days after surgery
Length of hospital stay
Length of hospital stay after surgery
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start18 Oct 2023
- Primary completion15 Oct 2025 (estimated)
- Study completion23 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized comparison between two analgesic techniques
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bravo Advis, University of Chile
- Investigators
- Daniela Bravo, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075004
- Sponsor's protocol ID
- OAIC 1379/23
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17403800Wainwright 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.
PubMed 31663402Giron-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.
PubMed 30063657Kuchalik 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.
PubMed 28850408Bravo 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.
PubMed 36948525Leurcharusmee 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.
PubMed 37028817
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06075004
- Acronym / sponsor ID
- OAIC 1379/23
- Conditions
- Hip Osteoarthritis, Postoperative Pain
- Keywords
- Nerve block, Periarticular infiltration, Hip replacement, Early rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 23 Oct 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized comparison between two analgesic techniques
| Arm | Type | Receives |
|---|---|---|
| Periarticular Local Anesthetic Infiltration | Active comparator | Procedure: Periarticular Local Anesthetic Infiltration60 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the periarticular level before wound closure. |
| Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block | Experimental | Procedure: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block45 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the posterior periarticular level before wound closure. After wound closure, an ultrasound-guided pericapsular nerve group block of the hip will be performed using ten mL of 0.5% bupivacaine with 5ug/mL epinephrine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periarticular Local Anesthetic InfiltrationSixty 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. | Procedure or surgery | Periarticular Local Anesthetic Infiltration |
| Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group BlockFrom 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. | Procedure or surgery | Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block |
Primary outcome
Presence of quadriceps motor block (defined as paralysis or paresis)
Time frame: 3 hours after post anesthesia care unit (PACU) arrival
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).
28 secondary outcomes
Presence of quadriceps motor block (defined as paralysis or paresis)
Time frame: 6 hours after post anesthesia care unit (PACU) arrival
Presence of quadriceps motor block (defined as paralysis or paresis)
Time frame: 24 hours after post anesthesia care unit (PACU) arrival
Hip adduction strength
Time frame: 3 hours after post anesthesia care unit (PACU) arrival
Hip adduction strength
Time frame: 6 hours after post anesthesia care unit (PACU) arrival
Hip adduction strength
Time frame: 24 hours after post anesthesia care unit (PACU) arrival
Postoperative morphine consumption
Time frame: 24 hours after PACU arrival
Postoperative morphine consumption
Time frame: 48 hours after PACU arrival
Time until first morphine demand
Time frame: 48 hours after PACU arrival
Static and dynamic pain
Time frame: 3 hours after PACU arrival
Static and dynamic pain
Time frame: 6 hours after PACU arrival
Static and dynamic pain
Time frame: 12 hours after PACU arrival
Static and dynamic pain
Time frame: 18 hours after PACU arrival
Static and dynamic pain
Time frame: 24 hours after PACU arrival
Static and dynamic pain
Time frame: 48 hours after PACU arrival
Sensory block
Time frame: 3 hours after PACU arrival
Sensory block
Time frame: 6 hours after PACU arrival
Sensory block
Time frame: 24 hours after PACU arrival
Block/Infiltration-related complications
Time frame: 1 hour after nerve block or local anesthetic infiltration
Postoperative opioid related side effects
Time frame: 48 hours after PACU arrival
Duration of surgery
Time frame: 4 hours after skin incision
Inability to perform physiotherapy due to motor block
Time frame: 6 hours after PACU arrival
Inability to perform physiotherapy due to motor block
Time frame: Postoperative day 1
Inability to perform physiotherapy due to motor block
Time frame: Postoperative day 2
Inability to perform physiotherapy due to pain
Time frame: 6 hours after PACU arrival
Inability to perform physiotherapy due to pain
Time frame: Postoperative day 1
Inability to perform physiotherapy due to pain
Time frame: Postoperative day 2
Readiness to discharge
Time frame: 4 days after surgery
Length of hospital stay
Time frame: 7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 17403800Kurtz 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.
- Background: PubMed 31663402Wainwright 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.
- Background: PubMed 30063657Giron-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.
- Background: PubMed 28850408Kuchalik 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.
- Background: PubMed 36948525Bravo 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.
- Background: PubMed 37028817Leurcharusmee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Bravo, MD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periarticular Local Anesthetic Infiltration and Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block in people with Hip Osteoarthritis and Postoperative Pain, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Bravo, MD (569222878209, dbravoadvis@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of quadriceps motor block (defined as paralysis or paresis) (time frame: 3 hours after post anesthesia care unit (PACU) arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075004, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.