Page 287 - EJMO-9-3

Eurasian Journal of
Medicine and Oncology Preperitoneal infiltration after laparoscopic cholecystectomy

participant was entitled to decline participation or resign However, to minimize bias, outcome assessors (those
from the study at any time without providing a rationale collecting VAS scores, analgesic use, and post-operative
or affecting their right to medical care. In addition, metrics) were blinded to group assignment, and patients
participants’ confidentiality was guaranteed through were unaware of their group allocation.
anonymous and coded data.
2.4. Allocation concealment
2.1. Inclusion criteria Allocation concealment was ensured via sealed opaque
The study included adult patients undergoing elective envelopes, and the treatment was administered by
laparoscopic cholecystectomy. Participants were required personnel not involved in outcome measurement. Forty
to have normal laboratory parameters, including a adult cases had a laparoscopic cholecystectomy. The
complete blood count, coagulation profile, and normal patients were randomly allocated into two equal groups.
liver and kidney function. They had to meet the American 2.4.1. TAP block group
Society of Anesthesiologists’ physical status classification
of I or II and be willing to provide informed consent. The group was given a bilateral ultrasound-guided TAP
block with 18 mL of the local anesthetic 0.25% bupivacaine
2.2. Exclusion criteria and 8 mg of dexamethasone (total volume 20 mL).
Patients who refused and those with a history of allergic 2.4.2. Preperitoneal group
reactions to local anesthetic drugs, a history of chronic
pain, a history of drug addiction, and those who had The group was preoperatively injected with local anesthetic
undergone complicated surgery were excluded from the through a preperitoneal local instillation of 18 mL of
study. the local anesthetic 0.25% bupivacaine and 8 mg of
dexamethasone (total volume 20 mL).
Complicated surgery refers to laparoscopic
cholecystectomy procedures involving additional Preoperatively, laboratory investigations, such as a
challenges beyond standard conditions, such as severe complete blood profile, coagulation profile, liver and
intra-abdominal adhesions, conversion to open surgery, kidney function, and age and weight, were conducted for all
significant bleeding requiring transfusion, and difficult patients as part of their routine preoperative investigations.
anatomical variations that prolong operative time. These The patient had been fasting for 8 h before the procedure.
9
cases were excluded to ensure homogeneity and minimize Patients enrolled were advised to have a fasting
variables that could affect post-operative outcomes. period of at least 8 h before surgery. All patients were
given 8 mg of intravenous ondansetron 15 min before
2.3. Randomization and blinding surgery, before the induction of anesthesia. Standard
The study employed a prospective, randomized, double- monitoring included pulse oximetry (Drager Fabius plus
blind design. Using a computer-generated randomization monitor, Drager Medical System, Inc., United States),
sequence, participants were randomly allocated into two electrocardiography, and non-invasive blood pressure
equal groups (TAP block or preperitoneal infiltration). measurement. General anesthesia was induced after 3 min
Allocation concealment was maintained using sealed, of preoxygenation by intravenous injection of 1–2 µg/kg
opaque envelopes opened only by a designated team fentanyl (Sunny Pharmaceutical, Egypt), 2–3 mg/kg of
member uninvolved in patient care. Both patients and propofol (B. Braun, Germany), and an induction dose of
outcome assessors were blinded to group allocation. The 0.5 mg/kg of atracurium (Sunny Pharmaceutical, Egypt).
anesthesiologist administering the block and the surgeon An endotracheal tube was inserted, and volume-controlled
performing the infiltration were aware of the allocation mechanical ventilation was initiated.
but did not participate in outcome assessment, ensuring Anesthesia was maintained with sevoflurane 2% with
unbiased data collection. controlled mechanical ventilation with 3L of oxygen and
Although the study is described as “double-blind,” it a maintenance dose of 0.1 mg/kg of atracurium. Positive
is important to clarify that the blinding was maintained pressure ventilation was initiated with an 8 mL/kg tidal
between the patients and the outcome assessors, not volume and an altered respiratory rate to preserve end-
the surgical or anesthesia team. The surgeon and tidal carbon dioxide between 45 and 35 mmHg. Baseline
anesthesiologist were necessarily unblinded due to the heart rate and mean arterial pressure measurements were
nature of the interventions—TAP block and preperitoneal documented and recorded every 10 min.
infiltration—which require direct procedural knowledge The surgery was conducted under general anesthesia by
and expertise. a single general surgeon, who adhered to a standardized

Volume 9 Issue 3 (2025) 279 doi: 10.36922/EJMO025180164