This study adheres to the CONSORT reporting guidelines. This randomized, double-blind, controlled study was conducted at Fayoum University Hospital in accordance with the principles enumerated in the Declaration of Helsinki, following approval by the Fayoum University Hospital institutional ethics committee and local IRB (No. M696). All participants submitted written informed consent prior to enrollment and randomization. The study was registered on ClinicalTrials.gov (
NCT06398600; in accordance with ICMJE standards).
The study comprised individuals aged 18 to 60 who were scheduled for elective lumbar spine fixation (LSF) and had a physical status of I or II, as defined by the American Society of Anesthesiologists (ASA). Refusal; contraindications to regional anesthesia (RA) (coagulopathy, injection site infection); previous lumbar disc surgery or spinal deformity; substance misuse; psychiatric disorders; allergy to LAs; and BMI > 35 kg/m² were the exclusion criteria.
Participants were randomly assigned to one of three groups (n = 37 each): Control (no block), caudal block (UGCB), or posterior QLPB, in a 1:1:1 ratio. A computer-generated sequence was used to randomize allocations, which were sealed in opaque envelopes and unsealed immediately prior to block performance. The investigation was administered on a patient- and assessor-blinded basis, as the performing anesthesiologist was unable to be blinded to the block technique. Through standardized draping and probe/needle placement, patients and outcome assessors were blinded to group assignment. To prevent unblinding, perioperative personnel were instructed to withhold block details, and independent anesthesiologists conducted postoperative assessments.
Noninvasive blood pressure, pulse oximetry, five-lead ECG, and capnography comprised the standard monitoring protocol. After five minutes of preoxygenation, propofol 2 mg/kg, fentanyl 1 µg/kg, and atracurium 0.5 mg/kg were administered to induce general anesthesia. Isoflurane (1.2 - 1.5%) was administered in air–oxygen to maintain anesthesia, and atracurium 0.1 mg/kg was administered every 20 minutes. In each instance, intravenous (IV) access was ensured.
Blocks were performed in the prone position following induction and hemodynamic stabilization via a LOGIQ P7 US system (GE Healthcare) with antiseptic covers and lubricant. Sensory block assessment was not feasible because all blocks were performed after induction of general anesthesia; therefore, dermatomal mapping could not be conducted.
The sacrococcygeal ligament and dorsal sacrum were identified by transversally positioning a linear 7 - 13 MHz transducer (or curvilinear 2 - 5 MHz in obesity) at the sacral hiatus, and subsequently rotating it longitudinally. Limiting advancement to ≤ 5 mm beyond the hiatus, an in-plane needle technique was implemented to penetrate the sacrococcygeal ligament and enter the caudal canal. The appropriate spread was confirmed by the unidirectional flow on color Doppler in the longitudinal view, following the administration of a 15 mL injection of 0.25% bupivacaine (AstraZeneca, Södertälje, Sweden) following negative aspiration (
8,
9).
A posterior QLPB (QLB type 2) was performed under ultrasound guidance and a sterile curvilinear ultrasound probe was positioned transversely in the triangle of Petit, between the costal margin and the iliac crest, to perform a posterior QLPB. The probe was then advanced posteriorly to visualize the QLM and the middle thoracolumbar fascia adjacent to the posterior aponeurosis of the transversus abdominis muscle. Using an in-plane technique, a needle was advanced into the fascial plane between the QLM and the middle thoracolumbar fascia. Following hydrodissection with 2–3 mL of saline to confirm correct needle tip placement, 15 mL of 0.25% bupivacaine was injected on each side to achieve a bilateral block (
10-
13).
Intravenous fentanyl at a dose of 0.5 µg/kg was administered to patients with inadequate intraoperative analgesia, which was defined as a >20% elevation in heart rate (HR) or mean blood pressure (MAP) from baseline (cumulative dose recorded). Thirty minutes prior to skin closure, all patients were administered 1 g of IV paracetamol and 4 mg of IV ondansetron. IV neostigmine 0.05 mg/kg and atropine 0.01 mg/kg were administered to reverse neuromuscular blockade at the conclusion of the surgery. The patients were transferred to the PACU for the purpose of monitoring their MAP, HR, SpO₂, and respiratory rate (RR).
On admission to the PACU and at 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively, the NPRS (0 - 10) was employed to evaluate analgesia outcomes. Intravenous meperidine 0.5 mg/kg was administered as rescue analgesia for NPRS ≥ 4 (meperidine was used in accordance with local institutional practice; however, we acknowledge that it is not part of many contemporary ERAS-based protocols). The time to first rescue and the cumulative 24-hour meperidine consumption were recorded. Over the course of 24 hours, hemodynamic parameters and intraoperative fentanyl supplementation were monitored every 30 minutes during the procedure and every 2 hours in the postoperative period. Systemic LA toxicity, hypotension, lethargy, paralysis, PONV, and neurological symptoms were prospectively documented. The duration of the operation was recorded.
The primary endpoint was the time to the initial rescue analgesia. Numerical Pain Rating Scale over 24 hours, total 24-hour meperidine consumption, additional intraoperative fentanyl, intra- and postoperative hemodynamics, complications, and operative duration were the secondary endpoints.
In order to identify a clinically significant difference in the primary outcome (time to first rescue), the sample size was determined via G*Power 3.1.9.6. The effect size was 0.68, as calculated by Ipek and co-authors (
14) (mean difference 2.89 h; group SDs 1.94 and 5.71). In order to account for attrition, a minimum of 35 participants per group was necessary, with α = 0.05 (two-sided), power (1 − β) = 0.80, and equal allocation (1:1:1). A total of 37 participants per group were enrolled. The primary endpoint was the focus of the calculation in order to reduce Type II error. Secondary endpoints were regarded as exploratory, and multiplicity adjustments were implemented as needed.
IBM SPSS Statistics v22 (IBM Corp., Armonk, NY, USA) was employed to conduct statistical analyses. The Shapiro-Wilk and Kolmogorov-Smirnov tests were implemented to evaluate normality. In contrast to Kruskal-Wallis tests, continuous variables that are normally distributed are reported as mean ± SD and compared via a one-way ANOVA. Non-normal variables are reported as median (IQR). Categorical data were utilized in contrast to χ² tests. Statistical significance was indicated by a two-sided P-value of less than 0.05. Bonferroni correction was implemented for post-hoc between-group comparisons subsequent to a significant omnibus test.
The raw data supporting the findings of this study are available from the corresponding author upon reasonable request.