After obtaining the Institution’s Ethics approval and written informed consent from the patients, the study was conducted in the Department of Anesthesia and postoperative unit. We proceeded with a prospective randomized, double-blind trial in sixty patients of ASA grade I and II who fulfilled the inclusion criteria, such as age group 20 to 60 yrs, elective surgery, and expected duration of surgery 1 to 2 hrs. Exclusion criteria were the surgeries extend to the upper abdomen, maximum handling of visceral organs, delayed surgical procedures, cesarean section, intubation followed by failure in spinal blocks, and unplanned intubations.
The patients were randomized by a sealed envelope to undergo TAP block (n = 30) in the study group (Group T) and (n = 30) in the control group (Group P), there was no TAP block, and only a standard analgesic regimen was administered. In both groups, Visual Analog Scale (VAS) pain scores were observed and documented at 30 min and 4, 8, 12, 16, 20, and 24 hrs postoperatively. Time taken for the first standard analgesic request and subsequent standard analgesic requirement frequency administered were also documented. The time period for the first analgesic request accounted here was the time taken after skin closure and TAP administration to the rescue analgesic supplementation in the study group.
In the control group (Group P), the analgesic regimen used was injection (Inj). Paracetamol 1gm IV and Inj. Tramadol 50 mg IV when a VAS score of four was observed, and the same was considered for subsequent requirement (
8). The time period for the first analgesic request in the control group accounted here was from skin closure to the above analgesic regimen administration. After TAP block, the first analgesia request was fulfilled using the same analgesic regimen mentioned above for the control group (Group P), which was administered when a VAS score of four was observed, and the same score was considered for the subsequent analgesic given. Frequency and time were documented.
All the patients were given spinal anesthesia using Inj. Bupivacaine 0.5% heavy 3.6 mL, at the end of the surgical procedure in the study group (Group T). The site between the anterio-lateral abdominal wall, iliac crest, and the subcostal margin was cleaned and draped. High-frequency ultrasonography (USG) probe was placed in the above plane; three muscles of the anterior abdominal wall were identified. A 50 mm 23 G needle was introduced anteriorly in the plane of USG probe for identification of neurofascial plane between the internal and transversus abdominis muscle. The needle is directed to approach the transverse abdominis plane (TAP). Once the needle entered the fascial plane, Inj. Ropivacaine 0.375% (15 mL unilaterally or 30 mL bilaterally) was administered after negative aspiration.
Patients were transferred to the recovery room, observation was done for 45 min, and then they were transferred to the postoperative unit. The assessments were carried out at 30 min in the recovery room and 4, 8, 12, 16, 20, and 24 hrs in the postoperative unit. We measured the pain severity using VAS from 0 to 10 (0 = No pain – 10 = Worst pain). The time for the first analgesic request and the frequency of subsequent analgesic requirements were documented.
The sample size calculation of 30 subjects in each group was done by assuming a power of 90% and alpha error of 0.05 based on Sforza et al.’s (
9) study where a mean difference of 1.7 was observed in the VAS scale. The statistical tool used for age, sex, and duration of surgery was analyzed using independent
t-test. Median, mean, and standard deviation (SD) were used at appropriate places. Chi-square test was used to find the association between the studied groups and VAS Scores. P < 0.05 was considered significant.