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Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.

ABSTRACT: INTRODUCTION:Total knee arthroplasty is a highly effective treatment for end-stage knee osteoarthritis, and it is usually performed under spinal or general anaesthesia with or without a surgical tourniquet. Some debate about the preferred mode of anaesthesia regarding patient outcomes remains. The aim of this study, which compares general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty, is to determine the optimal type of anaesthesia regimen and assess the effect of a tourniquet on the patient's recovery following total knee arthroplasty. METHODS AND ANALYSIS:This study is a randomised, controlled, parallel-group, four-arm study comparing spinal and general anaesthesia with and without a tourniquet in 400 patients undergoing fast-track total knee arthroplasty, with a 12-month follow-up. The primary outcome is cumulative intravenous oxycodone consumption by patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative nausea and vomiting, the length of hospital stay, the duration of the surgery, blood loss, demand for surgical unit resources, complications, readmissions, postoperative knee function, range of motion, health-related quality of life, prolonged pain and mortality. ETHICS AND DISSEMINATION:This study's protocol is in accordance with the declaration of Helsinki. The results of this study will be disseminated in international peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03364088; Pre-results.

SUBMITTER: Rantasalo MT

PROVIDER: S-EPMC6307602 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.

Rantasalo Mikko Tuomas MT Palanne Riku R Juutilainen Katarina K Kairaluoma Pekka P Linko Rita R Reponen Elina E Helkamaa Teemu T Vakkuri Anne A Olkkola Klaus T KT Madanat Rami R Skants Noora Kati Annukka NKA

BMJ open 20181222 12

<h4>Introduction</h4>Total knee arthroplasty is a highly effective treatment for end-stage knee osteoarthritis, and it is usually performed under spinal or general anaesthesia with or without a surgical tourniquet. Some debate about the preferred mode of anaesthesia regarding patient outcomes remains. The aim of this study, which compares general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty, is to determine the optimal type of anaesthesia regime ...[more]

PMID: 30580277

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Project description:BackgroundA combined intravenous and intra-articular regimen is one of the most effective administration routes of tranexamic acid (TXA) to reduce perioperative blood loss in unilateral total knee arthroplasty. However, there have been few reports regarding use of the combined regimen for patients undergoing simultaneous bilateral total knee arthroplasty, in which blood-management strategy is more challenging.MethodsWe compared perioperative blood loss in 30 consecutive patients undergoing simultaneous bilateral total knee arthroplasty who received both 1,000 mg of TXA intravenously and 1,000 mg of intra-articular TXA in each knee (combined TXA group) with that in a consecutive series of 51 patients who only received 1,000 mg of TXA intravenously (intravenous TXA group). Additional intravenous TXA was administered 6 hours after the initial administration in both groups. Except for the intraoperative TXA administration regimen, an identical perioperative blood-management strategy was applied to both groups; this consisted of transfusion of 800 or 400 mL of predeposited autologous blood except for patients with a preoperative hemoglobin level of <11.0 g/dL, who received 4 units of allogenic blood. All surgical procedures were performed with spinal anesthesia and without use of a pneumatic tourniquet. Perioperative blood loss was calculated using the blood volume and change in hemoglobin level from the preoperative measurement to postoperative day 3.ResultsThere was significantly less perioperative blood loss in the combined TXA group compared with the intravenous TXA group (mean and standard deviation, 1,201 ± 347 versus 1,638 ± 400 mL, respectively; mean difference, 437 mL; 95% confidence interval, 263 to 613 mL; p < 0.0001). No patient in the combined TXA group and 1 patient (2%) in the intravenous TXA group required additional allogenic blood transfusion. No thrombotic events occurred in either group.ConclusionsIn a nonrandomized comparison, combined intra-articular and intravenous TXA significantly reduced the calculated perioperative blood loss in simultaneous bilateral total knee arthroplasty compared with that found in patients treated only with intravenous TXA.Level of evidenceTherapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Project description:BACKGROUND:Postoperative outcomes following major surgery are influenced by surgical and anaesthesiological factors. While techniques of minimal invasive surgery have been associated with improved outcome, the techniques of minimal invasive, multimodal anaesthesia have not been adequately investigated. The aim of this study was to compare intrathecally based anaesthesia (ITA) including standardized, traditional intraoperative and postoperative care, with, general anaesthesia (GA) combined with intraoperative glucocorticoids, exclusion of intraoperative tourniquet and indwelling urethral catheter, and, an accelerated postoperative care regime. Outcome variables in the study were pain, requirement of analgesics, global satisfaction score and length-of-hospital stay. METHODS:Sixty patients were included and randomized to the ITA or the GA group. The ITA group received intrathecal bupivacaine (12.5 - 15.0 mg)/morphine (0.1 mg)/clonidine (0.03 mg), a standard surgical procedure, local infiltration analgesia (LIA) with ropivacaine (110 mg) /epinephrine (0.5 mg)/morphine (10 mg), an indwelling urethral catheter and mobilization with start Day 1 after the surgery. The GA group received a target-controlled infusion of propofol/remifentanil, betamethasone 4 mg i.v. intraoperatively, surgery was performed without a tourniquet, an indwelling urethral catheter was not used, LIA was with ropivacaine (250 mg)/epinephrine (0.3 mg) and mobilization was planned with start ? 2 hrs. after end of surgery. Outcomes were followed daily for the first 96 hrs. and at visits 3 months and 12 months postoperatively. RESULTS:Requirement of analgesics was decreased in the ITA group in the immediate postoperative period (P < 0.05). Pain scores were significantly lower in the ITA group (P < 0.01) between 0 - 12 hrs and in the GA group (P < 0.05) between 12 - 24 hrs after surgery. Fifteen of the patients in the GA group had to be intermittent catheterized due to bladder volumes > 400 mL. The LOS in the ITA group was significantly longer compared to the GA group (P < 0.01). There was no difference in global satisfaction score. CONCLUSION:General anaesthesia combined with intraoperative glucocorticoids and accelerated postoperative care, compared with, intrathecal blockade and traditional postoperative care, seems to generate the same overall pain ratings and a decrease in length-of-hospital stay, in patients undergoing elective total knee arthroplasty.

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Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.

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Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol.

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