The present study was a prospective interventional single-blinded, randomized controlled study. Institutional review board approval (ZUIRB#: 6818/14-1-2021) was obtained on 14-1-2021, and the study was registered at clinicaltrials.gov (NCT04899388) on 1/06/2021. The protocol was in accordance with the Declaration of Helsinki guidelines. Patients were enrolled from July 2021 to December 2021.
Sixty-nine elderly patients undergoing elective hip arthroplasty, with ages of 65 to 75 years old, American Society of Anesthesiologists Physical Status (ASA-PS) II and III, and a body mass index (BMI) of 25 to 30 kg/m2, were enrolled. Informed written consent was obtained from all patients.
Patients with mental health problems, a history of trauma or multiple fractures, uncontrolled hypertension, diabetes, coagulopathies, preexisting advanced diseases of the kidney or liver, heart disease, allergies (or other contraindications) to administrated drugs, as well as those with prolonged using of opioids, were excluded from the study.
However, group assignments and blocks were obscure to the observer, and an independent anesthesiologist recorded the primary and secondary outcomes. The surgeon and the attending anesthesiologist were not blinded. The primary outcome of the present study was the time to the first postoperative rescue analgesia, and secondary measurements were the oneset of sensory block, block performance time, EOSP scores, complications (such as hypotension, nausea, and vomiting), and patient satisfaction.
Patients eligible to join the study were contacted before the surgery to conduct a detailed clinical history taking and physical examination. On a numeric rating scale (NRS) of 0-10, the patients were taught and instructed to quantify their pain intensity (
12), where 0 indicated no pain, and ten was equal to maximum pain. The NRS score was recorded at the baseline and after the surgery. Patients were kept nil prior to the procedure (6 - 8 hours for solid meals and 2 hours for fluids).
After transferring the patient to the operating room, intravenous access was secured by an 18-G cannula. Standard monitoring equipment included an electrocardiogram device, pulse oximetry, and a noninvasive blood pressure monitoring device. The baseline parameters were recorded. All patients received oxygen supplementation by nasal cannula at the rate of 4 L/min and were premeditated with 0.03 mg/kg IV midazolam.
A computer-generated randomization table was used for random allocation. Before positioning for spinal anesthesia, patients were allocated to either of the three following groups (n = 23 per group):
(1) The PENG group, where patients received PENG block using 20 mL of bupivacaine 0.25%.
(2) The L-ESPS group, where patients received L-ESPS block using 20 mL of Bupivacaine 0.25%.
(3) The control group, in which patients received spinal anesthesia only.
3.1. Block Techniques
All blocks were carried out using low-frequency convex Sonosite M Turbo ultrasonography (FUJIFIM Sonosite, Inc., Bothell, WA, USA) after skin sterilization and draping.
PENG block: While the patient was laying in the supine position, the probe was initially placed in a transverse plane above the anterior superior iliac spine at the ipsilateral surgical site and then was rotated counterclockwise about 45 degrees to line up with the pubic ramus. The iliopubic eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle were all visible in this view (
Figure 1A). Using an in-plane technique from lateral to medial, a 22-gauge 80-mm needle was placed in the musculofascial plane between the psoas tendon (anterior) and the pubic ramus (posterior) (
6). The local anesthetic medication was delivered after negative aspiration while looking out for proper fluid distribution at a total volume of 20 mL of Bupivacaine 0.25% (
Figure 1B).
(A) The site of ultrasound probe placement in PENG. (B) Ultrasound-guided pericapsular nerve group (PENG) block. Red arrows: The lateral-to-medial insertion of the needle, AIIS: Anterior inferior iliac spine, IPE: Ilio-pubic eminence, FA: Femoral artery, Black arrow: The spread of local anesthetics.
L-ESPB block: The patient was positioned in the lateral decubitus posture at the ipsilateral surgical site. The convex USG transducer was moved from the midline to the side of the operation and positioned 4 – 6 cm lateral to the L3 spinous process on a longitudinal parasagittal plane. The needle was advanced using the in-plane superior-to-inferior approach until the tip was introduced up to the plane anterior to the "erector spinae muscle" and the posterior surface of the L3 transverse process (
Figure 2A). For hydro-dissection, 0.5 - 1 mL of normal saline 0.9% was administered to ensure the proper placement of the needle (
11). If there was any resistance during administering local anesthesia, the needle’s position was modified by drawing it back a few millimeters. Bupivacaine 0.25% (20 mL) was delivered between the transverse process and the erector spinae muscle (
Figure 2B).
(A) The site of ultrasound probe placement in ESPB. (B) Ultrasound-guided lumbar erector spinae block. Erector spinae muscles, L3: The transverse process of the third lumbar vertebra, red arrows: The spread of local anesthetics.
The block performance time was recorded as the time from the placement of the ultrasound probe on the patient’s skin to the end of the local anesthetic injection. Also, the oneset of the sensory block was recorded as the time from the end of the injection of local anesthetic (bupivacaine) to the loss of pinprick sensation using a sterile 25-G needle in the operation field.
Ease of Spinal Positioning (EOSP) (
13) was evaluated and recorded on a scale from zero to three (zero = unable to be positioned; one = abnormal posture of the patient due to pain requiring support for positioning; two = mild discomfort but no need for assisted positioning; three = optimal condition where the patient could sit without feeling pain).
If the patient’s EOSP was less than 2, an IV dose of fentanyl (20 µg) was administered every five minutes until the NRS score reached 2. The number of patients who needed fentanyl was recorded. Then patients were permitted to be seated for spinal anesthesia. A 26-G pencil-point needle was used to deliver spinal anesthesia in all groups using heavy bupivacaine 0.5% (1.8 mL) and fentanyl (20 µg, 0.4 mL) under strict sterile conditions.
After the end of the surgery and in the recovery room, pain intensity was assessed using a 10-point NRS [(0 = no pain, 10 = worst imaginable pain), 1 – 3: Mild pain (nagging, annoying, slightly interfering with activities of daily living (ADLs), 4 – 6: Moderate pain (significantly interfering with ADLs, 7 – 10: Severe pain (disabling, unable to perform ADLs)]. Pain intensity was measured both at rest and during movement (i.e., 45-degree passive flexion of the hip with flexed ipsilateral knee) 30 minutes after the end of the surgery, as well as 3, 6, 12, and 24 hours postoperatively. Postoperative analgesia was administered to all patients (IV administration of 1 g paracetamol every eight hours). If the postoperative NRS score was ≥ 3, rescue analgesia was administered (2 mg, IV bolus morphine) every 10 min until the NRS score fell below 3. The time (minutes) to the first episode of calling for rescue analgesia (morphine) was recorded in patients reporting NRS scores ≥ 3. The total dose of the rescue analgesic (morphine) consumed during the first 24 hours post-operation was recorded.
Patient satisfaction was evaluated using a 10-point satisfaction scale (0 = unsatisfied and 10 = most satisfied), 0 - 3 (not satisfied), 4 - 6 (partly satisfied), and 7 - 10 (highly satisfied) (
14). Postoperative complications, such as nausea, vomiting, hypotension, bradycardia, and hematoma, were recorded and managed accordingly.
3.2. Sample Size
According to a previous study (
15), assuming a mean time (hours) to the first call for opioids as 12 ± 6.7 in the PENG group and 6 ± 4.9 in the control group, 90% study power, 95% confidence interval (CI), and a drop-out rate of 10%, the sample size was estimated as n = 23 patients in each group using the (
Open Epi) database.
3.3. Statistical Analysis
All data were collected, tabulated, and statistically analyzed using SPSS for Windows, Version 23.0. (Armonk, NY: IBM Corp., released 2015). Quantitative data were expressed as mean ± SD & median (range), and qualitative data were expressed as frequency and percentage. The student t-test and Mann-Whitney U test were used to compare normally- and non-normally-distributed variables, respectively, between the two groups. The ANOVA and Kruskal-Wallis tests were used to compare normally- and non-normally-distributed variables, respectively, between more than two groups, followed by the Least significant difference to ascertain which two groups are different. The distribution of categorical variables was compared using the chi-square test. All the tests were two-sided at a P-value of < 0.05 as the statistical significance level. A P-value < 0.001 was considered highly statistically significant, and a P-value ≥ 0.05 was considered statistically insignificant.