Study population
muscle wasting disease, cancer, Steinert disease, allergy, pain, Duchenne, hypertension, NRS
AMYOTROPHIC LATERAL SCLEROSIS, STEINERT DISEASE, DIABETES MELLITUS, ALLERGY, RECRUITMENT, CORONARY HEART DISEASE, LIVER CIRRHOSIS, CANCER, RENAL INSUFFICIENCY, HYPERTENSION
This randomized controlled trial was approved by the Ethical Committee of Ziekenhuis Oost-Limburg, Genk (March 22, 2018-18/0010U-B371201835378) and was registered at clinicaltrials.gov (NCT03600454- July 26, 2018). Initially the hypothesis was planned to be tested in two independent, but complementary, studies in patients having bilateral THA (Arm 1;SA), and in patients having major abdominal surgery (Arm 2; epidural anaesthesia).Due to implementation of Enhanced Recovery After Surgery (ERAS) protocols in major abdominal surgery patients in our hospital after approval of this study epidural anaesthesia was abandoned, preventing recruitment of subjects in Arm 2. Consequently, the protocol was amended to eliminate Arm 2. All surgical procedures were performed by one surgeon using the anterior approach. Inclusion criteria were: (1) patients aged 18 years or older (2) bilateral THA. Exclusion criteria were: (1) inability to understand or give an informed consent; (2) urgent surgery; (3) contra-indications for SA; (4) allergy or contraindications to any products used in the protocol; (5) history of chronic opioid use; (6) preoperative use of corticosteroids [less than 3 months before surgery]; (7) history of muscle wasting disease [e.g., Steinert disease, amyotrophic lateral sclerosis; Duchenne dystrophy].Patient characteristics, American Society of Anesthesiologists (ASA) classification, comorbidities (diabetes mellitus, hypertension, coronary heart disease, renal insufficiency, liver cirrhosis, cancer), duration of surgery, total amount of anaesthetics administered, postoperative Numeric Rating Scale (NRS) pain scores, and total hospital length of stay were recorded. Written informed consent was obtained from each patient before inclusion in the study.