Methods
ESPB, bleeding, M546
CHRONIC PAIN, BLEEDING, LOCALIZED INFECTION, DRUG ALLERGY
According to the principles of the Declaration of Helsinki, this prospective clinical trial was conducted as a randomized, triple blinded, parallel-group study. The study at Fayoum University Hospital (M546) received approval from the ethical review board, and participants' written agreement was obtained. After being registered on ClinicalTrials.gov (NCT05072184; primary investigator: Mohamed Ahmed Hamed; date of registration: October 28, 2021; no study alterations or protocol amendments after trial commencement), the study was conducted at Fayoum University Hospital from October 2021 to July 2022 as part of this clinical trial. The applicable consortium recommendations were followed in this study.One hundred individuals who were over the age of 18 and had physical status I or II according to the American Society of Anesthesiologists (ASA) were included in the study.The following participants were excluded: patients who refused enrollment; significant kidney, liver, and cardiovascular conditions; a history of drug allergy under study; whenever there is a regional anaesthetic contraindication, such as a localized infection or bleeding issues; persistent opioid use; chronic pain history; and cognitive issues.Randomly, the patients were assigned to two groups: Preoperatively, under US guidance, the ESPB group (50) underwent bilateral ESPB with 20 ml of bupivacaine 0.25%. During the same procedure, 20 ml of saline were administered in a 1:1 ratio to the control group (50) using a computer-generated random table. The patient's assigned group information was taken from a sealed, opaque packet by the anesthesiologist who performed the ESPB but was not involved in any other data collection or patient care. The teams responsible for patient care and data collection, the surgical and anaesthetic teams, and the patients were blinded to the group assignments.