Methods
postoperative pain, nausea, shoulder pain, pain, cough, HO, right-side 2-quadrant block
INFILTRATION, INFILTRATE, SECONDARY, CREST, COMPLICATIONS, PNEUMOPERITONEUM
The study was designed as a prospective, randomized, controlled, and participant-blind study and carried out at the General Surgery, Anesthesiology, and Reanimation Departments of Private Medicabil Hospital, Bursa, Turkey, between September 2021 and March 2022 in adherence to the Declaration of Helsinki and the principles of Good Clinical Practice. The approval for the study was obtained from the Clinical Research Ethics Committee of Bursa Uludag University, Faculty of Medicine, Bursa, Turkey (no.: 2011-KAEK-26/55).Patients aged 18-70 years with American Society of Anesthesiologists (ASA) scores of 1 and 2 who underwent conventional 4-quadrant LC were included in the study. Those who refused to participate in the study, who underwent emergency surgery or open cholecystectomy, whose surgery was converted to open surgery, who had a body mass index of >40 kg/mPatients were randomized to the groups immediately before surgery using a computer-generated random number table and the surgeon was informed regarding the technique to be used for each patient. Patient’s data were recorded on a previously prepared form, and there was no record in this form to suggest the group of the patient. Although the surgeon and surgical team were not blinded, the anesthesia team and clinical nurses who carried out and recorded the postoperative assessments were blinded to the group of patients. In all groups, postoperative pain management was carried out by teams (clinical nurses and anesthesia team) who were blinded to the patient group by following standard orders, and the surgeon was not involved in this process. These forms were collected by the research coordinator nurse immediately before discharge and kept until the end of this study. The executive team was blinded of the results until the end of this study.Before starting this study, educational materials containing theoretical information, shape, and video on the regional anatomy and block administration were provided to the entire team who would carry out the block to standardize the level of knowledge. This study was started after the pre-application of 10 patients by the surgical team. All surgeries were carried out by 2 staff (HO and MN). Three 20 ml injectors were kept ready on the operating table for all patients undergoing LC included in this study, and normal saline (NS) or local anesthetic was withdrawn into the injector depending on the study group. In the BLTAP block group, the local anesthetic was diluted with saline and prepared as 40 ml of 0.25% bupivacaine (Marcaine, AstraZeneca). For the port-site injection of local anesthetic and ULTAP block, 20 ml of 0.5% bupivacaine (Marcaine, AstraZeneca) was used; thus, the total dose of local anesthetic was similar between the 2 groups.Patients were randomly assigned to the following groups: Group 1 (standard analgesia [SA] group, n=40): SA group received the block and port-site infiltration with NS. Group 2 (local anesthetic group, n=40): this group received the block with NS and port-site infiltration of anesthetic. Group 3 (ULTAP block group, n=40): following the port-site infiltration with NS, unilateral right-side 2-quadrant block (right subcostal and triangle of Petit) was carried out using bupivacaine, and left-side 2-quadrant block was carried out with NS. Group 4 (BLTAP block group, n=40): following port-site infiltration with NS, a bilateral 4-quadrant block (right and left subcostal and triangle of Petit) was carried out using bupivacaine. The administration techniques and dosages are shown in - After randomization, patients were assigned to each group and underwent the procedure. SA: standard analgesia, LA: local anesthesia, BLTAP: bilateral laparoscopic-assisted transversus abdominis plane block, ULTAP: unilateral laparoscopic-assisted transversus abdominis plane blockThe first port was inserted through the umbilicus after the anesthesia was induced, and a standard pneumoperitoneum pressure of 12 mmHg was established. The block was carried out by first inserting a 22-G needle just above the iliac crest through the midclavicular line posteriorly into the triangle of Petit under the direct view of the laparoscopic camera. The needle was then inserted below the costal arch through the midclavicular line toward the anterior axillary line into the subcostal plane. The block needle was advanced under direct view until the 2 pops were felt, and the extraperitoneal space was accessed avoiding puncture of the parietal peritoneum. The needle was withdrawn about 0.5 cm to infiltrate the thin transversus abdominis muscle fibers in the area. The position of the needle tip in this area was confirmed by visualization of Doyle’s bulge and the spread of the local anesthetic.- Surface landmarks for: A) transversus abdominis plane block; and B) Doyle’s bulge after the injection of local anesthetic.Laparoscopic surgery was carried out using the conventional safety technique with 2 trocars sized 5-mm and 2 sized 5-mm. The pouch was removed through the epigastric port using an endobag. The 10-mm trocar sites were closed using absorbable sutures in the fascial plane.After the transfer of patients to the operating room, an IV vascular access was established with a 22-gauge cannula, and 0.001 mg/kg midazolam was intravenously administered for sedation. Standard anesthesia monitoring included electrocardiogram (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2), end-tidal carbon dioxide (ETCO2), and bispectral index ([BIS], Aspect 1000 Systems, Aspect Medical Systems Inc., Natick) measurements. For the induction of anesthesia, 0.2 mg/kg fentanyl (Talinat, Vem Ilaç, Ankara), 0.6 mg/kg rocuronium bromide (Esmeron, Merck Sharp Dohme, Istanbul), and 1-2 mg/kg propofol (Propofol, Polifarma, Tekirdağ) were induced by titration. The depth of anesthesia was maintained with a mixture of 50% OA standard protocol was followed for postoperative analgesia in all groups. Acetaminophen 1 g (Parol, Atabey Kimya, Istanbul) was gradually administered every 6 hours depending on the level of pain, while diclofenac sodium was intravenously administered every 12 hours when required. Intravenous tramadol 50 mg (Contramal, Grunenthal, Germany) was given as a rescue analgesic to patients with a pain score higher than 4.Data on age, gender, height, weight, comorbidities, smoking status, length of hospital stay, operative time, intraoperative fluid volume, and complications of patients were collected using a standard form, after which intergroup comparisons were carried out. The primary outcome of this study was postoperative 1-, 3-, 6-, 12-, and 24-hours pain scores on the visual analog scale (VAS) during rest and cough.The secondary outcomes included the requirement for rescue analgesics, pre-discharge patient satisfaction (1: strongly disagree, 5: strongly agree [based on a Likert-type scale]), presence of shoulder pain, nausea and vomiting, and discharge duration exceeding 24 hours.