Methods
nausea, bleeding, postoperative pain, psychiatric illness, vasospastic disorder, pain, infection, De Quervain
BLEEDING, THROMBOANGIITIS OBLITERANS, LOCAL INFILTRATION, MINOR, TRIGGER FINGER, TENOSYNOVITIS, INFECTION, COMPLEX REGIONAL PAIN SYNDROME, CARPAL TUNNEL SYNDROME, RESOLUTION, DRUG ALLERGY
A prospective, randomized, and comparative study was conducted.The study was conducted after approval by the Ethics Committee (CAAE 34666920.3.0000.5505), and the patients’ signing of the informed consent form. All research was based on Resolution no. 466/12 of the National Health Council, which defines the guidelines and standards for research involving human subjects. The study was carried out according to the Consolidated Standards of Reporting Trials (CONSORT)The allocation of the participant to one of the two groups was as such. We used www.random.org to allocate numbers to patients and the group they would join. We had patients from 1 to 56 and groups 1 and 2. When a patient was scheduled to surgery, the hospital’s secretary, which was responsible for booking the surgery, would assign a ballot to the patient, that number would be from 1 to 56. Then, in a sheet she would see what group that number referred to. For example, the first patient to enroll the study could have been drawn the ballot number 42, which by random.org randomization would be group 2, for instance, and so on.To determine the sample calculation, a pilot project was conducted with 10 participants in each group, and the necessary information was obtained from it. Then, type error up to 0.05, and type-II error of 0.2 were applied, which results in study power of 80%, for a comparison test between independent groups, based on normal distributions. The pain score of 0 to 10 was employed for primary outcome, with the aim of identifying a minimum clinically significant difference of 2. Data from the pilot study of 10 participants were used to identify variability in the sample data, which identified a standard deviation of 2.7. Thus, it was identified that a sample size of 28 individuals in each group would be necessary to achieve a study power of 80%.The study included patients: 18 years of age or older; of either gender; ASA I or II, by the American Association of Anesthesiologists; undergoing minor hand surgery (carpal tunnel syndrome, wrist, and finger synovial cysts, De Quervain’s tenosynovitis, and trigger finger) confirmed by physical examination or complementary tests (ultrasonography, electroneuromyography); ambulatory; operated on by a physician specialized in hand surgery. The following patients were excluded: cognitively impaired (unable to understand the study); psychiatric illness; vasospastic disorder; thromboangiitis obliterans; infection at the puncture site; drug allergy; previous surgery; use of anticoagulants; and pregnant.WALANT group received lidocaine with epinephrine and sodium bicarbonate. In the procedure room out of the operating room, after antisepsis, the patient underwent local infiltration with 9 mL of 1% lidocaine with adrenaline 1:100,000 associated with 1 mL of 8.4% sodium bicarbonate according to the literatureIn the operating room, after monitoring the patient and obtaining venous access, propofol bolus and infusion were administered by the anesthesiologist. After local anesthesia made by the surgeon with 10 mL of lidocaine 1%, without adrenaline, the upper limb was exsanguinated with an Esmarch strip, and another strip placed near the axilla to keep the limb exsanguinated. Afterwards, a pneumatic tourniquet was inflated to 250 mmHg, and the surgery was performed without the use of electrocautery, followed by dressing and removal of the tourniquet. The patient was moved to the anesthesia recovery room, pending hospital discharge criteria: lucid, oriented patient, no pain, no nausea, stable vital signs, no signs of bleeding at the surgical siteAt discharge, patient was instructed to use dipyrone 1 g if pain ≥ 4 to 6 times a day. If pain persisted ≥ 4 times after dipyrone, the patient could take tramadol (50 mg) up to 400 mg a day. The patient was required to record the intensity of pain before medication administration.Patients were assessed for: need for complementary intraoperative analgesia, pain intensity by verbal numeric scale after seven days, 14 days and one month, patient comfort during surgeryThe primary outcome was a reduction in postoperative pain intensity. Secondary outcomes were a reduction in the need for analgesics and in the progression to complex regional pain syndrome.For statistical analysis, categorical data were described by their absolute occurrence and their relative frequency between groups, and the comparison between groups was performed by Pearson’s or Spearman’s chi-square test. Continuous data were tested for their distribution, Shapiro-Wilk’s test, and described by the mean and standard deviation. Student’s t-tests were used for pain intensity in the first week and age, the Mann-Whitney’s test for weight, height, duration of surgery, and pain intensity in the second week and one month, and the chi-square test for gender and complications/adverse effects. A p ≤ 0.05 was considered significant.