Postoperative Pain Clinical Trial
Official title:
A Randomized Comparison Between Periarticular Infiltration of Local Anesthetics and Ultrasound-Guided Pericapsular Nerve Group Block for Total Hip Replacement
Verified date | January 2023 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized trial is set out to compare the postoperative strength preservation capacity of local infiltration anesthesia (LIA) and pericapsular nerve group (PENG) block after performing a primary total hip arthroplasty (THA). The hypothesis is that LIA represents a superior alternative to PENG block in terms of strength preservation but providing effective analgesia during the first 24 postoperative hours after THA. Hence, the trial was designed as a superiority study hypothesizing a fivefold reduction in quadriceps paresis/paralysis at 3 hours.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 80 years - 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 = 01.4 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 of the corresponding surgical side - Previous hip arthroplasty due to hip fracture - Chronic pain syndromes requiring opioid intake at home |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clínico Universidad de Chile | Santiago | Metropolitan |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20. — View Citation
Bravo D, Layera S, Aliste J, Jara A, Fernandez D, Barrientos C, Wulf R, Munoz G, Finlayson RJ, Tran Q. Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial. J Clin Anesth. 2020 Nov;66:109907. doi: 10.1016/j.jclinane.2020.109907. Epub 2020 Jun 2. — 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
Husted C, Gromov K, Hansen HK, Troelsen A, Kristensen BB, Husted H. Outpatient total hip or knee arthroplasty in ambulatory surgery center versus arthroplasty ward: a randomized controlled trial. Acta Orthop. 2020 Feb;91(1):42-47. doi: 10.1080/17453674.2019.1686205. Epub 2019 Nov 4. — 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
Layera S, Saadawi M, Tran Q, Salinas FV. Motor-Sparing Peripheral Nerve Blocks for Shoulder, Knee, and Hip Surgery. Adv Anesth. 2020 Dec;38:189-207. doi: 10.1016/j.aan.2020.08.003. Epub 2020 Oct 1. No abstract available. — View Citation
Murphy TP, Byrne DP, Curtin P, Baker JF, Mulhall KJ. Can a periarticular levobupivacaine injection reduce postoperative opiate consumption during primary hip arthroplasty? Clin Orthop Relat Res. 2012 Apr;470(4):1151-7. doi: 10.1007/s11999-011-2108-3. Epub 2011 Sep 30. — 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
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 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 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 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 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 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 first postoperative day 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 second postoperative day 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 first postoperative day 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 second postoperative day 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 |
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