Effects of Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Opioid Consumption in Total Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial

Study Design and Randomization

This prospective RCT was conducted from July 2021 to May 2022, after approval by the Ethics Committee of the Second Affiliated Hospital of Anhui Medical University (approval no. YX2021-054[F1]) on June 29, 2021 and was prospectively registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=129578, ChiCTR2100048165; principal investigator: YW) on July 4, 2021. This study was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria [13] and in compliance with the Helsinki Declaration. Written informed consent was obtained from all patients.

Female patients who underwent elective TLH were enrolled in this study. The inclusion criteria were age between 18 and 65 years and American Society of Anesthesiologists (ASA) physical status of I–II. The exclusion criteria were a body mass index > 35 kg m−2, coagulopathy, history of opiate abuse, pre-existing chronic pain, allergy to local anesthetics or analgesics, infection at the injection site, mental or neurological disorders, severe cardiovascular disease, hepatic or renal insufficiency, and pregnancy or lactation.

Patients were randomly allocated to receive either ultrasound-guided ESPB (Group ESPB), TQLB (Group TQLB) or no intervention (Group CON) using computer software at a ratio of 1:1:1. An assistant, who was not involved in the study, prepared the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist who had performed over 200 TQLB and ESPB procedures and was unaffiliated with the study opened the envelopes to reveal the group allocation shortly before nerve block performance. Ultrasound-guided peripheral blocks were performed according to randomization. Thereafter, the surgeons, anesthesiologists, nurses providing postoperative care, investigators, and outcome assessors were blinded to the patients’ group allocation and did not have access to randomization until data analysis was complete.

Regional Anesthesia Technique

After arrival in the preoperative holding area, intravenous access was established and premedication (midazolam 0.02 mg kg−1 and sufentanil 0.1 μg kg−1) was administered. Vital parameters, including heart rate, electrocardiogram, blood pressure and pulse oximetry, were monitored throughout the procedure. All blocks were performed with a 22-gauge block needle using the same ultrasound machine (SonoSite M-Turbo; FUJIFILM Sonosite, Inc., Bothell, WA, USA). The patients were placed in a lateral decubitus position, and skin preparation was performed with 10% povidone-iodine. Bilateral ESPB and TQLB were performed as previously described [4, 14].

For ESPB, a linear ultrasound transducer (13–6 MHz) inside a sterile transparent plastic cover was positioned in a longitudinal orientation approximately 3 cm lateral to the midline at the T10 level to obtain a parasagittal view. After the tip of the T10 transverse process, the overlying erector spinae muscle and pleura were identified, the needle was inserted and in contact with the tip of the transverse process using an in-plane technique. After confirmation of the correct needle tip position by hydrodissection with normal saline, 25 ml of 0.4% ropivacaine was injected into the erector spinae plane between the tip of the transverse process and the erector spinae muscle on the left side. The same procedure with the same LA solution was injected at the T10 level on the right side (Fig. 1A–C).

Fig. 1figure 1

A schematic diagram of ESPB and TQLB. A The LA injected into the erector spinae plane was expected to extend to the paravertebral space, anesthetizing the thoracolumbar ventral rami and the sympathetic trunk which innervate the uterus and anterolateral abdominal wall. B Ultrasound image of ESPB at T10. C The LA was injected into the erector spinae plane between the tip of the transverse process and the erector spinae muscle. D The LA injected into the plane between the quadratus lumborum and the psoas major was expected to extend to the paravertebral space, anesthetizing the thoracolumbar ventral rami and the sympathetic trunk which innervate the uterus and anterolateral abdominal wall. E Ultrasound image of TQLB. F The LA was injected into the interfascial plane between the quadratus lumborum muscle and the psoas major muscle. ES erector spinae muscle, SG segmental ganglion, TP transverse process, QL quadratus lumborum muscle, PM psoas major muscle, EO external oblique muscle, IO internal oblique muscle, TA transversus abdominis muscle, VB vertebral body

For TQLB, a curvilinear ultrasound transducer (5–2 MHz) was placed in the transverse position immediately cranial to the iliac crest, at the level of the posterior axillary line. The needle was inserted in-plane in a posterolateral to anteromedial direction from the posterolateral edge of the probe until penetration of the medial part of the quadratus lumborum muscle, but without piercing the psoas major muscle. After confirmation of the correct needle tip position by hydrodissection, 25 ml of 0.4% ropivacaine was injected into the interfascial plane between the quadratus lumborum muscle and the psoas major muscle on the left side. The same procedure with the same LA solution was also injected on the right side after the patient was changed to the left lateral position (Fig. 1D–F).

In Group CON, the patients only received premedication in the preoperative holding area.

General Anesthesia Technique

After nerve block, patients were transferred to the operating room and received general anesthesia with standardized monitoring. Intravenous dexamethasone (8–10 mg) was administered to prevent postoperative nausea and vomiting (PONV). General anesthesia induction and tracheal intubation were performed using midazolam (0.05 mg kg−1), sufentanil (0.4 μg kg−1), etomidate (0.3 mg kg−1) and cisatracurium (0.2 mg kg−1). Parecoxib sodium (0.8 mg kg−1) was administered after induction for pre-emptive analgesia. Maintenance of anesthesia was achieved by continuous infusion with propofol (4–6 mg kg−1 h−1) and remifentanil (0.15–0.25 μg kg−1 min−1). The depth of anesthesia was adjusted to maintain a bispectral index target range of 40–60. Anesthesiologists administered intravenous sufentanil (5–10 μg) when the patient’s heart rate or blood pressure increased by > 20% from basal measurements.

Postoperative Management and Assessment

All patients were transferred to the post-anesthesia care unit for recovery after extubation (0 h postoperatively). A nurse blinded to the protocols instructed patients how to evaluate the incisional, visceral, shoulder and perineum pain [15] at rest and in motion using the 11-point Numeric Rating Scale (NRS), which ranges from ‘0’ (meaning no pain) to ‘10’ (meaning worst pain imaginable). Incisional pain was defined as a superficial pain, wound pain, or pain located in the abdominal wall, a pain that one can “touch”; visceral pain was defined as pain inside the abdomen, which may be deep, dull, and more difficult to localize, and may resemble a biliary pain attack; perineum and shoulder pain were defined as the sensation of pain in the perineum or shoulder, respectively. The sedation level was assessed using Richmond Agitation-Sedation Scale (RASS) [16] at 0.5 h postoperatively. Postoperative analgesia was maintained with sufentanil infusion using a patient-controlled intravenous analgesia (PCIA) device. The PCIA device administered a 3-μg bolus dose with a 15-min lock-time; no basal infusion and was initiated when the NRS score at rest was ≥ 4 or patients verbalized the need for pain relief. If three boluses of sufentanil did not alleviate pain, pentazocine 30 mg was administered intravenously as rescue analgesia. After transfer to the ward, patients used PCIA, as needed. The patient’s quality of recovery was assessed using the Quality of Recovery-15 (QoR-15) scale [14, 17, 18] at 24 h postoperatively. At 3 and 6 months postoperatively, the intensity of the patients’ average pain during the previous week was assessed using the NRS via telephone interview.

Outcomes

The primary outcome was cumulative sufentanil consumption at 12 h postoperatively. The secondary outcomes included cumulative sufentanil consumption at 24 h postoperatively; the RASS score at 0.5 h postoperatively; the NRS pain scores of incisional, visceral, shoulder, and perineal pain at rest and in motion, evaluated at 0.5, 2, 4, 6, 12 and 24 h after surgery; QoR-15 score at 24 h postoperatively; time to first PCIA; rescue analgesia requirement; time to first postoperative ambulation; block-related and anesthetic-related complications; postoperative length of hospitalization; and chronic pain in 3 and 6 months, postoperatively.

Sample Size and Statistical Analysis

The sample size was calculated based on the primary outcome of sufentanil consumption at 12 h postoperatively, using PASS V.15.0 (PASS, NCSS, USA) for Windows. Based on the results of our pilot study with six patients in each group (mean consumption of sufentanil at 12 h postoperatively was 3.5, 4.5, and 10.0 μg for Group ESPB, TQLB and CON, respectively, using a pooled standard deviation [SD] of 7.6), one-way analysis of variance (ANOVA) was selected and grouped into three groups; group allocation ratios were equal. At a power of 0.80 and an alpha error of 0.05, to account for 20% loss to follow-up, the required sample size for each group was calculated as 30. Thus, 90 participants were included in this study.

All statistical analyses were performed using SPSS Statistics (version 26.0; IBM, Armonk, NY, USA). Kolmogorov–Smirnov test and visual inspection of histograms were performed to assess data normality. Continuous variables were expressed as mean (SD) or median (interquartile range, IQR), and inter-group differences were assessed for significance using ANOVA for normally distributed data or Kruskal–Wallis test for nonparametric data followed by Bonferroni correction. Pairwise comparison for postoperative sufentanil consumption was analyzed using the Mann–Whitney U test, and by calculating the Hodge–Lehman median difference with a constructed 95% confidence interval (CI) with P < 0.0167 (0.05/3) was considered significant. Categorical variables were expressed as number (percentage) and intergroup differences were assessed using chi-squared or Fisher's exact tests in cases of expected frequency < 5. The time to first PCIA was analyzed using Kaplan–Meier survival analysis followed by log-rank test, with adjustment for multiple comparisons.

Repeated measurements of postoperative pain scores were analyzed using a linear mixed model [19, 20] to evaluate the association between NRS pain score over time and the intervention technique. This model included intervention, time and the interaction between time and intervention as the fixed effects. Time was included as a repeated effect; NRS pain scores were included as dependent variables. We corrected for comparisons between groups at multiple time points using Bonferroni correction. Assessments were 2-tailed, and statistical significance was set at P < 0.05.

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