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Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial.

ABSTRACT: BACKGROUND:Bupivacaine and levobupivacaine have similar pharmacokinetic and pharmacodynamic characteristics, and are used regularly in spinal anesthesia. Whether potential differences in their hemodynamic and anesthetic profiles could determine a differential risk of complications in elderly subjects, is controversial. The main objective was to compare the effects of intrathecally administered levobupivacaine (LB) versus bupivacaine (B), on regional cerebral O2 saturation during spinal anesthesia, cognitive status and neurological complications in elderly patients undergoing surgery for hip fracture. METHODS:This was a randomized, controlled, single blind study. 58 patients aged 70 or older undergoing surgery for hip fracture with spinal anesthesia were allocated with a 1:1 ratio to receive LB or B, combined with fentanyl 15??g, by intrathecal route. The primary outcome was the proportion of intraoperative time with regional cerebral desaturation (?20% reduction in regional cerebral oxygen saturation from baseline), monitored by near -infrared spectroscopy. Secondary endpoints included hemodynamic parameters, level of sensory and motor block, changes in Short Portable Mental Status Questionnaire (SPMSQ), and neurological complications. RESULTS:The mean percentage of intraoperative time with desaturation in the B group was 6.1% (SD: 17.5) and 4.7% (SD: 11.9) in the left and right hemisphere respectively; in the LB group the mean was 4.8% (SD: 11.4) in the left hemisphere and 2.4% (SD: 8.3) in the right one. No statistically significant differences were found between treatment groups. The level of sensory block at the start of surgery was lower for LB than for B (Th10 vs Th8, p:0.047) and motor block at 15?min was lower for LB (2.5 vs 3, p:0.009). No differences in postoperative SPMSQ were observed. Neurological complications such as confusional state, agitation or disorientation were reported in 50% of patients in the B group and 21.4% of patients in the LB group, p?=?0.05. CONCLUSIONS:No statistically significant differences in regional cerebral oxygen saturation or hemodynamic parameters were observed between both treatment groups. Bupivacaine and levobupivacaine differed in sensory and motor block achieved. While no differences were observed in cognitive impairment measured by the SPMSQ between treatment groups neurological complications reported by the physician were more frequent with bupivacaine. TRIAL REGISTRATION:European Union Clinical Trials Register ( EudraCT 2013-000846 -20 ) (April 9th, 2013). ClinicalTrials.gov ( NCT01960543 ) (September 23rd, 2013).

SUBMITTER: Vives R

PROVIDER: S-EPMC6357488 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial.

Vives Roser R Fernandez-Galinski Diana D Gordo Francisca F Izquierdo Alberto A Oliva Joan C JC Colilles Carmen C Pontes Caridad C

BMC anesthesiology 20190131 1

<h4>Background</h4>Bupivacaine and levobupivacaine have similar pharmacokinetic and pharmacodynamic characteristics, and are used regularly in spinal anesthesia. Whether potential differences in their hemodynamic and anesthetic profiles could determine a differential risk of complications in elderly subjects, is controversial. The main objective was to compare the effects of intrathecally administered levobupivacaine (LB) versus bupivacaine (B), on regional cerebral O<sub>2</sub> saturation duri ...[more]

PMID: 30704463

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Project description:Various advantages of isobaric bupivacaine, levobupivacaine, and hyperbaric bupivacaine are described. There are no studies reliably determining the benefits of these forms of bupivacaine. The purpose of the study was to compare the efficacy of spinal anesthesia (SA) performed with 0.5% isobaric bupivacaine, 0.5% levobupivacaine, and 0.5% hyperbaric bupivacaine. The clinical study was approved by the ethics committee. The sample size was calculated for a confidence level of 99%. 111 patients were randomly allocated into 3 equal groups for spinal anesthesia in lower limb surgeries. In group 1 (1B) spinal anesthesia was performed with 3 ml of 0.5% isobaric bupivacaine (n = 37); in group 2 (2L)-3 ml of 0.5% levobupivacaine (n = 37), in group 3 (3H)-3 ml of 0.5% hyperbaric bupivacaine (n = 37). The criterion for assessing the effectiveness of anesthesia was the need to switch to another type of anesthesia (criterion-no anesthesia), or the need for additional use of narcotic analgesics or local anesthesia during surgery (criterion-reporting of painful feelings during the operation). In 1B anesthesia efficiency by the criterion of additional intraoperative analgesia was 100% (37 patients; 95% CI [0.88-1.0]); 2L-86.4%; (31 patients; 95% CI [0.68-0.92]); 3H-72.9% (27 patients; 95% CI [0.56-0.84]). There were significant differences between groups 1B and 2L: p < 0.05 (p = 0.0104). There were no significant differences between groups 2L and 3H (p = 0.2587). All patients in group 1B developed complete sensory block (++) within 4 (3; 5) min. In group 2L complete sensory block developed in 34 patients (89.4%) within 9 (5; 14) min, in group 3H sensory block developed in all patients within 3 (2.5; 4). The duration of analgesia period between 1B and 2L did not statistically differ (p = 0.73). In 3H the duration of analgesia was 170 (150; 200) min. The study found 83.7% efficacy of levobupivacaine and 72.9% efficacy of hyperbaric bupivacaine in comparison with isobaric bupivacaine (100%) when administered intrathecally in equal volumes and amounts (by the criterion of additional intraoperative analgesia).Trial registration: NCT05184465 (Initial Release: 12/01/2021; date of first publication-11/01/2022).

Project description:Background: Osteoporotic fractures are associated with a loss of quality of life, but only few patients receive an appropriate therapy. Therefore, the present study aims to investigate the awareness of musculoskeletal patients to participate in osteoporosis assessment and to evaluate whether there are significant differences between acute care patients treated for major fractures of the hip compared to elective patients treated for hip joint replacement.; Methods: From May 2015 to December 2016 patients who were undergoing surgical treatment for proximal femur fracture or total hip replacement due to osteoarthritis and were at risk for an underlying osteoporosis (female > 60 and male > 70 years) were included in the study and asked to complete a questionnaire assessing the awareness for an underlying osteoporosis. ASA Score, FRAX Score, and demographic information have also been examined. Results: In total 268 patients (female = 194 (72.0%)/male = 74 (28%)), mean age 77.7 years (±7.7) undergoing hip surgery were included. Of these, 118 were treated for fracture-related etiology and 150 underwent total hip arthroplasty in an elective care setting. Patients were interviewed about their need for osteoporosis examination during hospitalization. Overall, 76 of 150 patients receiving elective care (50.7%) considered that an examination was necessary, whereas in proximal femur fracture patients the awareness was lower, and the disease osteoporosis was assessed as threatening by significantly fewer newly fractured patients. By comparison, patients undergoing trauma surgery had a considerably greater risk of developing another osteoporotic fracture than patients undergoing elective surgery determined by the FRAX® Score (p ≤ 0.001).; Conclusions: The patients' motivation to endure additional osteoporosis diagnostic testing is notoriously low and needs to be increased. Patients who underwent acute care surgery for a fragility proximal femur fracture, although acutely affected by the potential consequences of underlying osteoporosis, showed lower awareness than the elective comparison population that was also on average 6.1 years younger. Although elective patients were younger and at a lower risk, they seemed to be much more willing to undergo further osteoporosis assessment. In order to better identify and care for patients at risk, interventions such as effective screening, early initiation of osteoporosis therapy in the inpatient setting and a fracture liaison service are important measures.

Project description:The analgesic and sedative effect of clonidine explain its common use as adjuvant in regional anesthesia, however the hemodynamic instability associated with its neuroaxial administration is the major drawback. Our study hypothesis is to compare the hemodynamic and analgesic effect of epidural fentanyl in comparison to meperidine when added to clonidine in patients undergoing lower limbs orthopedic surgery using combined spinal-epidural anesthesia.One hundred thirty five ASA physical status I or II patients were recruited for lower limb orthopedic surgery. All received 2 mL intrathecal 0.5 % hyperbaric bupivacaine, 10 mL epidural 0.25 % plain bupivacaine, and 1 mL epidural clonidine 2 ?g/kg (Clonidine group) and then either 1 ml fentanyl 25 ?g (Fentanyl Group) or 1 ml meperidine 25 mg (Meperidine Group). The quality of surgical anesthesia, incidence of hypotension and bradycardia, intra-operative pain assessment, and onset of postoperative pain, sedation scores and side effects in the postoperative period were recorded.The 1(st) analgesic requirement in the postoperative period was significantly prolonged in the meperidine group (p = 0.001). Significant decrease in the mean arterial blood pressure in fentanyl group was at 15, 30, 45, 60 and 90 min (p = 0.035, 0.019, 0.027, 0.032 and 0.039) respectively, significant decrease in meperdine group was at 15 and 30 min (p = 0.038 and 0.043), while in clonidine group a significant decrease was at 15, 30, 45, and 60 min (p = 0.025, 0.028, 0.036 and 0.042) respectively. Among group changes, the mean arterial blood pressure was significantly higher in meperdine group at 30, 45, 60 and 90 min (p = 0.007, 0.015, 0.029 and 0.033) respectively. A significant decrease in the heart rate in fentanyl group at 15, 30 and 45 min (p = 0.035, 0.018 and 0.029), in meperdine group a significant decrease in the heart rate was at 15 min (p = 0.038), while in clonidine group a significant decrease was at 15, and 30 min (p = 0.016 and 0.003) . Among group changes, the heart rate was significantly higher in meperdine group at 30, 45 and 60 min (p = 0.021, 0.017 and 0.011). VAS were significantly lower in meperdine group in comparison to fentanyl and clonidine groups at 2 h, 3 h and 4 h post-operative period (p = 0.024, 0.001 and 0.039).The combined administration of epidural clonidine and meperidine provided better intraoperative hemodynamics and prolonged postoperative analgesia than epidural clonidine fentanyl combination in patients undergoing lower limb orthopedic surgery.Clinical Trail Registry (Clinicaltrail.gov) NCT 02128451 .

Dataset Information

Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial.

Publications

Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial.

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