Efficacy of Dexamethasone as an Adjuvant to Bilateral Erector Spinae Plane Block for Lumbar Laminectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
Laminectomy is a routine procedure for patients with lumbar spinal stenosis, offering significant benefits such as reduced low back pain, alleviation of radiculopathy, and improved motor strength 1 23. Despite these advantages, postoperative pain remains a challenge for anesthesiologists. According to Davin et al., approximately 80% of patients undergoing lumbar laminectomy experience postoperative discomfort, with 20% developing persistent postsurgical pain (PPSP). The application of erector spinae plane (ESP) block in lumbar laminectomy surgery significantly reduces postoperative pain and hospital length of stay. However, ESP block without adjuvants has limitations in duration. Adjuvants are thus required to optimize the effects of ESP block 4.
Dexamethasone is a glucocorticoid that is widely used in the perioperative setting. Interfascial administration of dexamethasone has been shown to prolong the duration of analgesia provided by the peripheral nerve blocks. Pehora et al (2017) reported that perineural dexamethasone with local anesthetics prolongs sensory blockade, effectively reducing postoperative pain intensity and opioid consumption. Its analgesic effects likely stem from anti-inflammatory mechanisms, including supression of proinflammatory cytokines, induction of anti-inflammatory cytokines, reduced prostaglandin synthesis, and decreased neuronal excitability 5 6. Adjuvant dexamethasone provides additional benefits, including prolonged analgesia, reduced pain scores, lower postoperative opioid requirements, and decreased inflammation in patients undergoing lumbar laminectomy.
Prior literature has not examined the benefits of dexamethasone as an adjuvant for lumbar ESP block, nor measured and compared inflammatory biomarkers with its use. Therefore, this study investigates the efficacy of dexamethasone adjuant in ESP block for lumbar laminectomy surgery by assessing postoperative prostaglandin E2 levels, analgesia duration, pain scores (VAS) at 8, 12, 16, and 24 hours postoperatively, and patient-controlled analgesia (PCA) fentanyl requirements at the same intervals.
详细描述
This study is a single-center, double-blind randomized controlled trial conducted in the Central Surgical Installation operating room at Ngoerah General Hospital, Denpasar, Indonesia, from March to August 2025, following ethical approval (No. 0326/UN14.2.2.VII.14/LT/2025). Participants were patients undergoing lumbar laminectomy during the study period. Consecutive sampling was employed. Inclusion criteria were age 18-65 years, American Society of Anesthesiologists (ASA) physical status I-III, and body mass index (BMI) 18-30 kg/m2. Exclusion criteria included contraindications to regional anesthesia, puncture site infection, type 2 diabetes mellitus, drug allergy, chronic opioid use, laminectomy involving >2 segments, or inability to assess Visual Analog Scale (VAS) pain or inability to use paient-controlled analgesia (PCA). Dropout criteria were hypotension >30% from baseline requiring continuous vasopressors or postoperative mechanical ventilation.
Sample size calculation determined 36 participants, randomized 1:1 into two groups using computer-generated simple randomization: Group P1 (n=18) received erector spinae plane (ESP) block with dexamethasone adjuvant, and Group P2 (n=18) received ESP block without dexamethasone. The study flowchart is shown in Figure 1.
All participants provided written informed consent. Upon arrival in the operating room, blood samples were collected for baseline prostaglandin E2 measurement. General anesthesia was induced with standard monitoring (SpO2, ECG, respiratory rate, noninvasive blood pressure) using propofol (2-3 mg/kg), fentanyl (1-2 mcg/kg), and rocuronium (0.6 mg/kg). Patients were then positioned prone for ESP block. Group P1 received 20 mL of 0.375% ropivacaine with 5 mg dexamethasone per side; Group P2 received 20 mL of 0.375% ropivacaine per side.
Anesthesia was maintained with sevoflurane, adjusted to achieve a minimum alveolar concentration of 1.2. Intraoperative analgesia included Paracetamol 1 g. Ondansetron 8 mg was administered for postoperative nausea and vomiting prophylaxis. Postoperative analgesia consisted of fentanyl PCA, oral paracetamol 500 mg every 6 hours, and oral ibuprofen 400 mg every 8 hours. Postoperative assessments were performed by the Acute Pain Service team, with blood sampling for Prostaglanin E2 at 24 hours postoperatively.
Primary outcome were postoperative prostaglandin E2 levels, analgesia duration, VAS pain score at 8, 12, 16, and 24 hours postoperatively, and fentanyl PCA requirements at the same intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
"This is a double-blind study designed to ensure that both the investigators and the participants are unaware of the group assignments. To maintain blinding, the investigator responsible for data collection and analysis is different from the operator performing the Erector Spinae Plane (ESP) block procedure. Participants are provided with a standardized explanation and informed consent; since the procedure is identical for both groups and only the adjuvant (dexamethasone or none) differs, the participants remain blinded to their specific treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 - 65 years
- •ASA physical status I-III
- •Patients with a BMI of 18 - 30 kg/m2
排除标准
- •Patients with contraindications to regional anesthesia
- •Infection at the puncture site
- •Type 2 Diabetes Mellitus (T2DM)
- •Hypersensitivity or allergy to the medications used
- •Prolonged or chronic opioid use
- •Laminectomy involving more than two segments
- •Inability to be assessed using the Visual Analogue Scale (VAS) or to operate the PCA device
研究组 & 干预措施
ESPB With Dexamethasone
The dexamethasone-ESPB group receives a bilateral Erector Spinae Plane Block with a regimen consisting of 0.375% ropivacaine and 5 mg of dexamethasone, administered in a total volume of 20 ml on each side (right and left) of the back
The intervention is : Erector Spinae Plane Block
干预措施: Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg (Drug)
ESPB Without Dexamethasone
The non-dexamethasone ESPB group receives a bilateral Erector Spinae Plane Block with a regimen consisting of 0.375% ropivacaine, administered in a total volume of 20 ml on each side (right and left) of the back
The intervention is : Erector Spinae Plane Block
干预措施: Bilateral ESPB: Ropivacaine 0.375% (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: From the completion of the ESP block until the first request for rescue analgesia (assessed up to 24 hours post-surgery)
This represents the duration of analgesia, defined as the time from the administration of the Erector Spinae Plane (ESP) block until the patient first presses the Patient-Controlled Analgesia (PCA) fentanyl button. The data is presented in minutes.
Postoperative increase in PGE2 levels
时间窗: PGE2 Levels Preoperatively (baseline) and 24 hours after surgery
The mean baseline prostaglandin E2 (PGE2) level was significantly lower in the dexamethasone group than in the non-adjuvant group (9.36 ± 2.57 vs 12.72 ± 4.35 ng/L; p = 0.008). The median postoperative increase in PGE2 was also significantly smaller in the dexamethasone group compared with the control group (7.03 \[IQR 13.79\] vs 19.05 \[IQR 34.56\]; p = 0.016)
Postoperative VAS pain scores at 8, 12, 16, and 24 hours
时间窗: 8, 12, 16, and 24 hours after the surgery done
Postoperative Visual Analogue Scale (VAS) is a pain assessment score widely used in research and clinical practice to evaluate the intensity of subjective experiences, such as pain or discomfort, consisting of a 100 mm line with descriptive anchors. Assessments were performed at 8, 12, 16, and 24 hours postoperatively. Numerical variables are presented as mean and standard deviation (SD) for normally distributed data, or as median and interquartile range (IQR) for non-normally distributed data.
Postoperative PCA Fentanyl requirements
时间窗: 8, 12, 16, and 24 hours after surgery
Postoperative fentanyl PCA requirements. These represent the postoperative fentanyl requirements at 8, 12, 16, and 24 hours, as recorded by the Patient-Controlled Analgesia (PCA) pump, starting from the Post-Anesthesia Care Unit (PACU) up to 24 hours postoperatively. Numerical variables are presented as mean and standard deviation (SD) for normally distributed data, or as median and interquartile range (IQR) for non-normally distributed data
次要结局
未报告次要终点
研究者
Albertus Medianto Walujo
Medical Doctor, Resident of Anesthesiology and Intensive Care Therapy
Udayana University