This randomized controlled clinical study received approval from our institute's Ethical Committee of Scientific Research at the Faculty of Medicine, Ain Shams University Hospital, Cairo, Egypt (FAMSU MD80/2023). It was registered with Clinical Trials (registration No NCT06097286). We obtained written informed consent from 75 patients, aged 21 to 60, who were undergoing upper abdominal surgeries and had physical status I-I based on their American Society of Anesthesiologists (ASA) score. Exclusion criteria included those who declined to participate, were younger than 20 or older than 60, or had physical status III-IV according to ASA with a history of coagulopathy and bleeding disorders (INR > 1.6 and PTT > 50 sec), a LA allergy, pre-existing myopathy or neuropathy, an injection site infection, a history of chronic pain syndromes, or a history of long-term opioid or steroid use prior to surgery.
A nurse randomly selected the envelope indicating the assigned group using computer-generated random numbers concealed in opaque, sealed envelopes. Seventy-five patients were randomly assigned into three equal groups of 25 patients each. This study followed a parallel trial design, utilizing block randomization. Five blocks were used to randomize the 75 cases with an allocation ratio of 1:1:1. Each block contained 5 patients per group, totaling 15 patients per block and 75 across all five blocks. The EOIP group received a US-guided EOIP block. The ESP group received a US-ESP block. The Control group did not receive any blocks and received postoperative IV analgesia according to hospital protocol (morphine 0.1 mg/kg). All blocks were administered by an experienced anesthesiologist. Group allocation was blinded to anesthesia residents, surgeons, and patients. The anesthesia residents, responsible for patient follow-up and data collection, were not involved in any other aspects of the study or the drugs used.
3.1. Sample Size
Assuming an effect size difference of 0.4 across groups with respect to post-operative Visual Analog Scale (VAS) score and after a 5% correction for dropout rate, the sample size was calculated using the PASS 15 program. Using an F test with a 0.0500 significance level, the entire sample of 75 patients (25 in each group) provides 82% power to detect differences between the means against the alternative of equal means. The effect size f = om / o, or 0.4000, indicates the magnitude of the mean variation. Based on the findings of prior relevant studies [Malawat et al. (
4) and Elsharkawy et al. (
2)], an expected effect size of 0.40 was assumed to detect differences in postoperative VAS scores among the three study groups.
Preoperative evaluations included a comprehensive history, clinical examination, regular laboratory tests including complete blood count, liver function test, kidney function test, prothrombin time, and partial thromboplastin time, as well as routine investigations including electrocardiography (ECG) and chest X-ray. All selected patients were informed in detail about the purpose of this study, the procedure, and the potential adverse effects. Written informed consent was obtained.
Inside the operating theatre, intravenous access was secured, standard monitoring was applied, and all procedures were conducted under complete aseptic conditions. Baseline mean arterial blood pressure (MAP), heart rate (HR), ECG, and oxygen saturation (SpO2) were recorded. Intravenous propofol 2 mg/kg, atracurium 0.5 mg/kg, and fentanyl 2 μg/kg were used for induction and analgesia. After relaxation, an endotracheal tube of standard size (appropriate for the patient) was used for intubation. Anesthesia was maintained with a 50:50 oxygen to air mixture, 1 vol% to 1.5 vol% isoflurane, and mechanical ventilation to achieve an end-tidal CO2 of approximately 35 mmHg. Throughout the procedure, intraoperative monitoring of the capnograph, ECG, HR, MAP, and SpO2 was maintained.
In the EOIP Group, a high-frequency linear probe of the Fugi film-Sonosite® M-Turbo US system was positioned at the anterior axillary line at the sixth intercostal space in a longitudinal parasagittal orientation, following surgery and prior to the end of anesthesia. Using an in-plane technique, a 21G 10 cm needle was inserted. The needle tip was advanced into the fascial plane on the deep aspect of the external oblique muscle. A total of 20 mL of the LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2%, and 5 mL of normal saline) was administered. For the other side (if necessary), the same process was repeated.
In the ESP Group, a high-frequency linear probe of the Fugi film-Sonosite® M-Turbo US system was positioned 2.5 - 3 cm laterally to the T9 spinous process in a longitudinal parasagittal orientation, following surgery and prior to the end of anesthesia. The muscles of the erector spinae were found to be superficial to the T9 transverse process tip. Using an in-plane technique, a 21G 10 cm needle was inserted. The needle tip was advanced into the fascial plane on the deep aspect of the erector spinae muscle. On US imaging, the erector spinae muscle was lifted off the bone silhouette of the transverse process by a visible fluid spread, confirming the needle tip's position. A total of 20 mL of the LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2%, and 5 mL of normal saline) was administered. For the other side (if necessary), the same process was repeated.
In the Control Group, patients did not receive any blocks and received postoperative IV analgesia according to hospital protocol (morphine 0.1 mg/kg). Postoperative hemodynamic parameters, including HR and MAP, were recorded immediately at PACU admission and at 2, 4, 6, 8, 12, 18, and 24 hours. All patients received IV paracetamol (10 - 15 mg/kg) every 8 hours for postoperative pain management. Postoperative pain and opioid consumption were assessed using the VAS. Patients with VAS > 3 received IV pethidine (25 - 50 mg) as a second rescue analgesia until VAS became ≤ 3. Postoperative adverse effects, such as nausea and vomiting, were recorded and treated. The time to start mobilization was also recorded.
The study’s primary outcome was the total 24-hour pethidine intake after surgery. The secondary outcomes included the rate of requesting pethidine, duration of technique, ease of technique, VAS scores at rest and during movement, HR, MAP, occurrence of postoperative complications such as nausea and vomiting, and the time to start mobilization. The endpoint was 24 hours postoperatively.