This study was designed as a randomized, double-blind clinical trial. The study population consisted of patients classified as the American Society of Anesthesiologists (ASA) class I and II, aged between 35 and 65 years, who were candidates for shoulder surgery and referred to Akhtar and Shohada hospitals in Tehran, Iran. Based on the pilot study and the sample size in similar studies, with a confidence level of 95% and a test power of 90%, a total of 60 individuals were enrolled. The subjects were randomly allocated into two groups of 30 each: The experimental and control groups.
The inclusion criteria comprised an age range of 35 to 65 years, no substance abuse within the past 6 weeks, ASA I-II, lower limb orthopedic surgery under spinal anesthesia, absence of background diseases (e.g., ischemic heart disease, diabetes mellitus, and hypertension), absence of substance addiction according to the definition, normal body temperature, no history of tremors, seizures, tremors, or Parkinson's disease, no non-steroidal anti-inflammatory drug (NSAID) consumption 24 hours prior to surgery, absence of infections or wounds, absence of known allergies, no pregnancy or lactation, maximum surgery duration of 3 hours, and patient satisfaction. The exclusion criteria included the occurrence of adverse events requiring intervention within 24 hours after the surgery, requiring blood transfusion during surgery and anesthesia, and a decrease in the patient's core body temperature below 32 degrees Celsius during surgery. The ethical criteria for this study were adhered to by obtaining approval and consent from the Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran, with ethics code IR.SBMU.RETECH.REC.1401.754.
3.1. Procedure
After identifying suitable patients, necessary explanations regarding the procedure, benefits, and potential risks of participating in the study were provided, and written informed consent was obtained from the patients. The patients who met the necessary criteria were randomly assigned into two groups: The experimental and control groups, with 30 individuals in each group, while age and gender homogeneity were ensured. After patients entered the operating room, they were examined by an anesthesiologist, and their ASA class was determined.
Following the placement of an intravenous (IV) line and standard monitoring, the skin was disinfected using an antiseptic solution. A transverse view with a probe covered by a sterile drape was obtained, and the brachial plexus network was identified between the anterior and middle scalene muscles. A 22-gauge needle was used under ultrasound guidance for the supraclavicular, infraclavicular, and axillary regions of the upper limb. In the control group, a mixture of 2 cc of 0.5% bupivacaine (20 milligrams) and 2 cc of sterile water was injected between the C5 and C6 cervical roots. In the experimental group, 2 cc of 0.5% bupivacaine and 2 cc of the perineural dexamethasone compound were injected.
The success of motor block is defined as the inability to abduct the shoulder and sensory block with a pinprick test at the surgical site. The study was considered double-blind in the sense that, firstly, the patients and the anesthesiologist were unaware of which group each person was in, and only the researcher was aware that he/she was not in direct contact with the patients. Secondly, due to the doctor's lack of knowledge of injecting the medicine, it was pulled into the syringe by another person and handed over to the anesthesiologist.
Pain intensity after surgery was assessed using the Visual Analog Scale (VAS) at 12 hours and 24 hours after the surgery. The VAS pain scale indicates the overall pain of patients. It is represented as a 10-centimeter line, and pain intensity is graded between 0 to 10 centimeters. A score of 0 indicates no pain, scores 1 to 3 indicate mild pain, scores 4 to 6 indicate moderate pain, and scores 7 to 10 indicate severe pain (
8). The internal reliability of this tool has been reported as 0.85 to 0.95 (
9). For data analysis, means, standard deviations, frequencies, tables, and charts were used to categorize and summarize the collected data. To assess the normal distribution of the data, the Kolmogorov-Smirnov test was employed due to the number of observations in each distribution. Considering the fulfillment of statistical assumptions, the independent
t-test and repeated measures analysis of variance (ANOVA) were applied at a 95% confidence level using SPSS software version 22.