A Phase 2/3 interventional study of 0.5% Ropivacaine and Normal saline in Arthritis of Hip, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Sunnybrook Health Sciences Centre · Phase 2/3, Interventional, and Treatment
Total hip replacement (THR) is a common and major surgical procedure performed in elderly patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic modalities could play a significant role in minimizing the risk of adverse events in the perioperative period and potentially shorten time to discharge and recovery.
Establishing a safe and effective post-operative analgesic plan is of central importance to successful THR anesthesia care. The application of ultrasound visualization has improved the efficacy of the fascia iliaca compartment block (FICB). However, ultrasound-guided suprainguinal FICB has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following THR.
The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia in the first 24 hours than without a block.
The search for the optimal pain treatment strategies is a work in progress. As techniques and technology evolve so should our approach for the best analgesic regimen that would minimize unwanted side effects and potential risk and more importantly improve patient satisfaction.
The literature has supported the use of peripheral nerve blocks for analgesia as well as improved functional outcome after total knee arthroplasty. The addition of peripheral nerve blocks for THR has been more controversial, as the only effective nerve block, the posterior approach to the lumbar plexus, is an advanced regional technique with potential for serious complications. The application of ultrasound visualization has improved the efficacy of the infrainguinal fascia iliaca block. However, ultrasound guided suprainguinal fascia iliaca block has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following primary hip arthroplasty.
The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia than that obtained using the landmark "2-pop" technique and the infrainguinal blocks.
The aim of this study is to assess whether the ultrasound guided suprainguinal fascia iliaca block can provide superior early postoperative analgesia in patients undergoing primary hip arthroplasty, and minimizing the pain immediately after the resolution of the spinal anesthetic.
The investigators propose to perform the first triple-blinded RCT examining the early analgesic efficacy of ultrasound-guided suprainguinal FICB after THR (lateral approach) under spinal anesthesia.
Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
Drug: 0.5% Ropivacaine
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.
Drug: Normal saline
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
Also known as: Naropin
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.
Opioid Consumption at 24 hours after arrival in post-operative care unit
Opioid consumption at 24 hours after arrival in PACU amongst the various treatment groups will be our primary outcome. Opioid usage for the first 24 hours will be simply determined from the patient-controlled analgesia data in addition to oral narcotics administered.
Time frame: 24 hours
Pain Scores
Numerical Rating Scale (NRS-11) for pain will be used (0=no pain, 10=terrible pain) as the secondary outcome measure. The NRS score will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours at rest and during mobilization by the treating ward nurse.
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Respiratory Depression
Respiratory rate will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Respiratory depression will be defined as respiratory rate less than 10 breaths per minute.
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Nausea
Nausea will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N \& V 1. = Mild N \& V, no treatment required 2. = Severe N \& V, treatment required 3. = Treatment effective 4. = Treatment ineffective
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Vomiting
Vomiting will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N \& V 1. = Mild N \& V, no treatment required 2. = Severe N \& V, treatment required 3. = Treatment effective 4. = Treatment ineffective
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Pruritus
Pruritus will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Pruritus Scale: 0 = No pruritis 1. = Mild pruritis, no treatment required 2. = Severe pruritis, treatment required 3. = Treatment effective 4. = Treatment ineffective
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Plan to share: Undecided
Ran from Aug 2018 to primary completion in Apr 2022, 43 months.
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Studies of the drug tested here: Ropivacaine
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