From May to October 2020, 60 female patients aged 45 - 60 years were scheduled to undergo the surgery of total abdominal hysterectomy anesthesia spinal anesthesia. They were in ASA Physical Status Classes I and II at the Gynecologic Department of the Tanta University Hospital and enrolled in this randomized prospective study.
The study was approved by the Research Ethics Committee of the Faculty of Medicine of the Tanta University (Code: 33799/4/20 registered on the ClinicalTrials.gov website (ID: NCT04382274)). From May to October 2020, 60 female patients aged 45 - 60 years were scheduled to undergo the surgery of total abdominal hysterectomy under spinal anesthesia. They were in ASA Physical Status Classes I and II at the Gynecologic Department of the Tanta University Hospital and participated in this randomized trial.
The participants were excluded due to injection site infection, local anesthetics allergy, bleeding issues, mental or physical diseases affecting the pain score assessment, morbid obesity, liver failure, and renal failure.
Routine preoperative laboratory testing was performed for all participants. Pulse oximetry, non-invasive blood pressure monitoring, and electrocardiography were all performed when the patient first arrived in the operating room. The following vital signs were recorded at baseline. An intravenous line (IV) was placed, and IV fluid administration began. Oxygen was delivered by nasal cannula at a rate of 4 liters/ minute, and spinal anesthesia by 25 mcg fentanyl and 15 mg hyperbaric bupivacaine was carried for the two groups.
After confirming an adequate dermatomal blockade level (to at least the T8 dermatome), the 60 individuals were randomly assigned to either the QLB or dual TAB groups (30 patients each). After constructing a list of numbers, each one was wrapped in an opaque envelope and referenced to one of the two groups. An anesthesiologist then delivered one of the envelopes to each patient and assigned them to one of the two groups based on a comparison to the computer-generated list. The block was conducted by an anesthesiologist not participating in data collection and result analyses.
Both blocks were carried out using an ultrasonic machine, a probe sheathed in sterile material under strict aseptic conditions (China, Sonoscape® SSI-6000 with 12-6 MHz linear probe with high or low frequency), and 22G, 100 mm needle (B Braun Medical Inc., Bethlehem, PA, USA).
The dual-TAB group had bilateral ultrasound-guided dual TAB (integrating II nerve blocks with TAB). The layers of the external, internal, and transverse oblique muscles (EO, IO, TA) were found when the probe was positioned at the anterior axillary line between the lower costal margin and the iliac crest. Then 20 mL of bupivacaine 0.25% was injected between the TA and IO muscles after negative aspiration. On the other hand, a similar strategy was adopted. The umbilical–anterior superior iliac spine (ASIS) line was used to scan the abdomen for IINB. The ilioinguinal nerve runs between the transverse and internal oblique nerves. Following a negative aspiration, 10 milliliters of bupivacaine 0.25% was injected. On the other side, a similar technique was used.
In the QLB group (anterior termed QLB3), to get greater exposure in this group, the operating table was inclined to the opposite side. Above the iliac crest, a convex low-frequency probe was mounted vertically, and an anteromedial needle was inserted into the plane via QL. Between the QL and PM muscles, the tip of the needle was inserted. PM, QL, and erector spinae act as the "three cloves of the shamrock," while the transverse process of L4 serves as the "stem" of the "shamrock symbol," and the precise needle site was confirmed with hypoechoic imaging and the hydro dissection of 1 - 2 mL of normal saline following negative aspiration. On the other side, the procedure was performed once more with a 20 mL injection of 0.25% bupivacaine (
7).
The same surgeon performed an open hysterectomy with a low transverse incision in both groups. All patients received a gram of paracetamol IV about 30 minutes before the operation. The patients were transported to the post-anesthesia care unit (PACU) after being released from the operating room.
Age, body mass index (BMI), Physical Status Class of American Society of Anesthesiologists (ASA), duration of anesthesia, and surgery duration were all involved in the demographic data. The VAS for pain (an analogue scale with 0 representing no pain and 10 representing maximum discomfort) was used to measure the severity of postoperative pain at intervals of half an hour and 2, 4, 6, 12, and 24 hours. Three milligrams of morphine was administered intravenously to patients with VAS = 4. A one-gram intravenous paracetamol infusion was given to the patients with VAS = 4. The total quantity of morphine consumed after surgery (rescue analgesia) and the duration of postoperative analgesia during the first 24 hours after surgery (the interval between recovery and the first dosage of morphine), as well as the number of individuals who required rescue analgesia, arrhythmia, bradycardia (50 beats/min), postoperative hypotension (systolic arterial pressure 90 mmHg), vomiting or nausea, lower limb muscular weakness, as well as any additional complications, were also recorded.
3.1. Statistical Analysis
The G*Power tool, edition 3.1.9.2 (University of Düsseldorf, Düsseldorf, Germany), was used to calculate the sample size. Each group requires a sample size of 26 instances regarding the following parameters: 0.05 error and 90% power to demonstrate a 35% reduction in the need for postoperative morphine (the primary outcome) with QLB versus TAB/ IINB (according to a prior study). To prevent dropout, four instances were added to each group (
8). IBM SPSS software version 20.0 was used to analyze the data used as the input to the computer (IBM Corporation, Armonk, New York). When analyzing and comparing categorical variables between the two groups, the chi-square test (Fisher's Exact correction) was used to investigate the distribution normality of the variables. The Mann-Whitney test was used to compare both groups with non-normally distributed quantitative data, whereas the student
t-test was used to compare both groups with normally distributed quantitative data. In this study, P < 0.05 was set as the significance level.