Spinal Anesthesia Clinical Trial
Official title:
Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study
NCT number | NCT06155903 |
Other study ID # | 2-2023-533 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | June 15, 2024 |
Verified date | June 2024 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Femur Fractures (PF) are nowadays one of the main social and health problems in industrialized countries. PF are defined as crack or break of the proximal femur and they represent an important cause of morbidity and mortality in elderly population. The main prospective and retrospective studies do not show the superiority of subarachnoid anesthesia over general anesthesia in terms of 30-day mortality and post-operative complications, however they always recommend the execution of PeripheralNerve Blocks (PNB). Loco-regional anesthesia plays a fundamental role in the treatment of peri-operative pain assuring better hemodynamic stability and has already fully entered national and international pain management protocols, because it allows faster recovery times with a reduction in the use of intravenous analgesic drugs in particular opioids and consequently a faster discharge and a reduction in peri-operative complications and the costs of assistance. The aim of our study will be to propose an anesthetic approach based on PNB that could be particularly suitable for frail patients especially when Neuroaxial Anesthesia (NA) is not feasible due to difficulty to position the patient or to the withdrawal time of anticoagulant or antiplatelet therapies.
Status | Completed |
Enrollment | 78 |
Est. completion date | June 15, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | "Inclusion Criteria" : - Subject has signed and dated an Informed Consent Form - Subject is classified as a ASA (American Society of Anesthesiologists) status I-IV - Subject is age over 65 years old - Subjects with femur fracture, candidates for intramedullary nailing surgery, to be operated on within 48 hoursPatients undergoing total hip arthroplasty "Exclusion Criteria": - Age younger than 65 years - Subject with contraindications to subarachnoid technique or peripherical nerve blocks - Subject with local anesthetic allergy - Subject in whom the treatment protocol could not be fully applied were excluded from this study. - Study refusal - Neurological disease of the lower limbs |
Country | Name | City | State |
---|---|---|---|
Italy | University of Naples Federico II | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to motor block regression (duration of motor block) | Time to motor block regression (duration of motor block), defined as the time between complete block (score 1) after T0 of local anesthetic injection and no motor block (score 4) on the Bromage scale (1, complete motor block, unable to move feet or knees; 2, almost complete motor block, able to move the feet only; 3, partial motor block, just able to move the knees; 4, none, full flexion of knees and feet;). Motor block will be evaluated before and 10, 15 and 20min after T0, and thereafter, every 30 minutes during surgery, and every hour in the postoperative period until its complete regression | Motor block was assessed immediately after the locoregional procedure, up to 24 hours postoperatively. | |
Primary | Postoperative pain evaluated by VAS scales | The VAS assessment will be done with a 10-cm-long line with verbal anchors at both ends ("no pain" on the far left and "the most intense pain" on the far right). The patient will mark a dot on the line corresponding to the pain intensity rating. | Every 6 hours during treatment until the first 24 postoperative hours | |
Primary | Postoperative pain evaluated by PAINAD scales | The PAINED scale (Pain Assessment in Advanced Dementia Scale) assesses 5 items: facial expression, breathing, negative vocalizations, consolability and body language with a range from 0 to 10 (1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). | Every 6 hours during treatment until the first 24 postoperative hours | |
Secondary | Rate of postoperative nausea and vomiting (PONV) | We will analyze the risk factors of postoperative nausea and vomiting (PONV) by administering an Apfel score to each patient, practicing intraoperative and postoperative antiemetic treatment in accordance with the 2020 Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. | Every 6 hours during treatment until the first 24 postoperative hours | |
Secondary | rescue dose analgesics needed | interval between anesthesia and first rescue dose.Pharmacological therapy will be based on the patients' responses. After surgery, we will administer intravenous paracetamol 1 g 3 times a day. Ketorolac 30 mg (not for glomerular filtration rate < 50 ml/min) or Oxycodone (up to 0.1mg/Kg) mg will be available as rescue dose. Pain control will be considered good in case of VAS and PAINED score less than or equal to 4. | From the end of treatment to 24 hours postoperatively | |
Secondary | surgical compliance | will be obtained with a 5-point Likert scale score filled out by the surgeon. | 1 hours after surgery | |
Secondary | The duration of surgery (min) | The duration of surgery (min), assessed as Planned time(min) and Effective time(min) | 4 hours after skin incision | |
Secondary | Rate of Delirium | Postoperative delirium (POD) is an acute and fluctuating alteration of mental state of reduced awareness and disturbance of attention, which begins in the recovery room and occurs up to 5 days after surgery. POD will be detected by "3-Minute Diagnostic Confusion Assessment Method" (3D-CAM) and has four features: (1) altered mental status/fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking [27]. For the prevention and treatment of POD, we will follow the 2017 European Society of Anesthesiology guidelines. | Every 6 hours during treatment until the first 24 postoperative hours |
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