Arthroplasty, Replacement, Hip Clinical Trial
— HALFOfficial title:
Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty
Fascia iliaca compartment block (FICB) is a documented option for postoperative analgesia for total hip arthroplasty (THA) surgery. FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available motor sparing techniques are not as effective as FICB for analgesia. Low concentration local anesthetics (LCLA) are used with excellent results for pain control with no or minimum motor block effect, in other scenarios (highlighted in obstetric anesthesia) and techniques (epidural anesthesia, for instance). This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia, while at the same time avoiding motor blockade and muscle weakness. The investigators hypothesize that LCLA-FICB, when compared to conventional high concentration local anesthetics (HCLA) FICB, provides similar postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 30, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing primary THA in the inpatient setting. - Non-pregnant patients older than 21 years of age. - Patients with American Society of Anesthesiologists (ASA) physical status I-IV. - No alcohol or drug dependency. Exclusion Criteria: - Patients undergoing outpatient THA. - Chronic opioid use of 30 mg or more of oral morphine equivalent, per day, for the last 2 consecutive weeks. - Contraindications for nerve block placement (severe anatomic abnormalities, local or systemic infection). - Contraindications for any of the standardized medications used for the study (Mepivacaine, Fentanyl, Dexamethasone, Ondansetron, Acetaminophen, Celecoxib, Hydromorphone). - Not submitted to the standardized spinal anesthesia technique. - Need to conversion to general anesthesia after the start of the surgery. |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20. — View Citation
Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11. — View Citation
Li D, Yang Z, Xie X, Zhao J, Kang P. Adductor canal block provides better performance after total knee arthroplasty compared with femoral nerve block: a systematic review and meta-analysis. Int Orthop. 2016 May;40(5):925-33. doi: 10.1007/s00264-015-2998-x. Epub 2015 Oct 10. — View Citation
Panzenbeck P, von Keudell A, Joshi GP, Xu CX, Vlassakov K, Schreiber KL, Rathmell JP, Lirk P. Procedure-specific acute pain trajectory after elective total hip arthroplasty: systematic review and data synthesis. Br J Anaesth. 2021 Jul;127(1):110-132. doi: 10.1016/j.bja.2021.02.036. — View Citation
Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quadriceps muscle strenght | Intensity of quadriceps strength: Muscle Strength Grading (Oxford Scale): 0 - no muscle activation; 1 - trace muscle activation, such as a twitch, without achieving full range of motion; 2 - muscle activation with gravity eliminated, achieving full range of motion; 3 - muscle activation against gravity, full range of motion; 4 - muscle activation against some resistance, full range of motion; 5 - muscle activation against examiner's full resistance, full range of motion. | 4 hours after spinal anesthesia | |
Secondary | Pain scores | Numerical verbal scale (0 = no pain at all, 10 = worst pain) | 24 hours after spinal anesthesia | |
Secondary | Opioid consumption | Amount of opioids (in oral morphine equivalents) needed by patients on the first 24 hours after spinal anesthesia | 24 hours after spinal anesthesia |
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