Study design and participants
cardio-cerebrovascular diseases, abnormal blood coagulation, allergy, fractures, hypertension
RESPIRATORY INSUFFICIENCY, ALLERGY, CORONARY HEART DISEASE, HEART FAILURE, HYPERTENSION, OBSTRUCTIVE EMPHYSEMA, PUNCTURE SITE INFECTION
This is a single-centre double-blind, randomized controlled trial of 50 patients with American Society of Anaesthesiologists (ASA) I-II at our hospital (Teaching Hospital, Residency training Hospital). This study was performed in line with the principles of the Declaration of Helsinki. Hospital ethics committee approval was obtained before starting patient enrolment (No: 2020-462). Written informed consent was obtained from all participants. The trial was registered prior to patient enrolment at the Chinese Clinical Trial Registry on 25 October 2020 (ChiCTR2000039383).The subjects were patients with unilateral clavicle fractures who underwent elective internal fixation of clavicle fractures in our hospital. The patients were randomly divided into two groups: patients with SCPB and CPB were included in group I, and patients with SCPB and ISBP were included in group II. There were 25 patients in each group. An anaesthesiologist (who did not participate in the other steps) was responsible for recruiting patients and determining random grouping with the use of random-number tables. On the day of operation, a nurse anaesthetist (who was blinded to the scope of the study) opened the envelope, determined the grouping of patients and was responsible for the preparation of regional anaesthesia drugs. The second anaesthesiologist (who was blinded to the patient group allocation) was responsible for the regional anaesthesia operation. The second nurse anaesthetist (who was blinded for patient group allocation) was responsible for evaluating the scale, recording research data and postoperative follow-up. The exclusion criteria were as follows: (1) cardio-cerebrovascular diseases (history of heart failure, poor control of hypertension, coronary heart disease and cerebrovascular history); (2) respiratory insufficiency (bilateral rib fractures, obstructive emphysema, etc.); (3) abnormal blood coagulation; (4) puncture site infection; (5) continuous use of analgesics for the last 3 months; and (6) allergy to local anaesthetics. All data were collected from Neusoft and MedicalSystem Technology.