Study design and participants
drug abuse, allergy, pain, psychiatric, neurological deficits, sepsis, NRS
CARDIOVASCULAR DISEASES, RESPIRATORY DISORDERS, ALLERGY, DISORDERS, COAGULOPATHY, SEPSIS
We conducted a prospective randomized comparative pilot study in the pain clinics of Mansoura University Hospital, Egypt, from January 2022 to September 2022. We obtained approval from the Institutional Research Board (IRB) of the Mansoura University Faculty of Medicine on 28/11/2021 (Code number: R.21.11.1523.R1). The study was registered on Clinicaltrials.gov on 14/1/2022 (NCT05192278) and was conducted in accordance with the Helsinki Declaration. After providing a clear explanation of the study details, we obtained informed written consent from all study participants.The inclusion criteria were as follows: females who had undergone mastectomy surgery more than six months ago, aged over 18 years old, experiencing postmastectomy pain that was not relieved by medical treatments alone (such as magnesium 100 mg/day, anticonvulsants, antidepressants, or EMLA cream), with a Numeric Rating Scale (NRS) score greater than four. Additionally, participants needed to have a body mass index (BMI) of less than 30 and be classified as American Society of Anesthesiology Physical Status (ASAPS) class I or II. The NRS was used to assess and express their pain levels, ranging from 0 to 10, with ten representing extreme pain and zero representing no pain.The exclusion criteria were as follows: patient rejection, systemic or local sepsis, allergy to the medications used in the study, coagulopathy, distorted local anatomy, uncontrolled cardiovascular diseases, neurological deficits, respiratory disorders, psychiatric disorders, or a history of drug abuse.