Methods
coagulopathies, infections, pain, NRS pain, allergies, nerve damage, NRS, Cancer
PNEUMOTHORAX, COAGULOPATHIES, ADVERSE EVENTS, INFECTIONS, STERILE, SECONDARY, ALLERGIES, CHRONIC PAIN, CANCER
This prospective, randomized comparative study was conducted at M. Bufalini Hospital, Cesena, Italy, and Santa Maria delle Grazie Hospital, Ravenna, Italy, from April 2020 to November 2021.It included 82 adult females, aged 18 to 90 years with an American Society of Anesthesiologists (ASA) risk ranging from I to IV, with no contraindications for the execution of TPV and ESP blocks, scheduled for elective modified radical mastectomy (MRM) with or without axillary dissection.The study was approved by the ethics committee of the AUSL (Azienda Unità Sanitaria Locale- local health authority) of Romagna (Ref. 2149/2020 I.5/299) and IRST (Istituto Romagnolo Studio Tumori—Institute for Cancer Study of Romagna) and was prospectively registered on Clinicaltrials.gov (trial identifier NCT04457115, first registration 27/04/2020).The full trial protocol is available from the corresponding author.Patients with allergies and/or contraindications for the administration of drugs used in the study were excluded from the study, as well as patients who presented with chronic opioid use for therapeutic purposes, patients with coagulopathies and/or who used antiaggregant or anticoagulant drugs, with infections and lesions at the puncture site or with a Body Mass Index (BMI) ≥ 40.The primary outcome for this study was NRS pain score 12 h after surgery.The secondary outcomes were:NRS pain score at different time point: at the awakening of the patients (time 0) and 2, 6, 24 and 36 post-operative hoursPatients who needed rescue analgesic (non-steroidal anti-inflammatory drugs—NSAIDs)Intra- and post-operative opioid consumptionPONVLength of stayPatients with adverse events (accidental vascular puncture, accidental pneumothorax, nerve damage, and Horner’s/Harlequin’s syndrome)Post-operative chronic pain assessment (6 months)Patients’ satisfaction regarding anesthesiologic procedureAll patients were admitted to the hospital after having followed an anesthetic visit in pre-hospitalization in the morning on the day of surgery and received premedication with midazolam 3 mg intramuscularly one hour before the surgery, only if requested by the patient.Furthermore during the visit, the patients were instructed on what is meant by NRS scales.In all cases the same six anesthesiologists performed the blocks and the same two surgeons performed the surgery.In the pre-anesthesia holding area, standard monitoring, including non-invasive blood pressure, electrocardiogram, pulse oximetry, and Bispectral Index System (BIS, Covidien Medtronic, Minneapolis, MN, USA) were applied.Both blocks was performed thirty minutes before the surgery with a sterile technique and out of plane approach using hydrolocation with 0.9% saline to help show the position of the needle tip, with the patients placed in the lateral position with the surgical site being uppermost.The ultrasound guidance (SonoSite M-Turbo, SonoSite Inc., Bothell, WA), with a 16–6 MHz linear probe and 22-G × 50-mm needle (Echoplex + , Vygon, Ecouen-France) positioned into a longitudinal orientation to obtain a para-sagittal view, was used for both the blocks.