NCT07429708

Dexamethasone as ESPB Adjuvant in Lumbar Laminectomy

Efficacy of Dexamethasone as an Adjuvant to Bilateral Erector Spinae Plane Block for Lumbar Laminectomy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Udayana University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Descriptive data are presented as mean ± standard deviation. Normality was assessed using the Shapiro-Wilk test. Between-group comparisons used the independent t-test for normally distributed data or Mann-Whitney U test for non-normal data. Clinical interpretability was evaluated using 95% CI of the Difference. Analyses were performed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA).

Conditions

• Laminectomy
• Postperative Pain Management
• Prostaglandin E2
• Lumbal Disc Herniation

Interventions

Type	Name	Description
DRUG	Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg	Initial identification is performed using ultrasound (USG) guidance. Once the erector spinae muscle and the transverse process are clearly visualized, local anesthetic infiltration is administered using 1-2 ml of 2% lidocaine. A Stimuplex needle is then inserted in a cranio-caudal direction deep into the erector spinae muscle using an in-plane approach until it makes contact with the lateral edge of the transverse process, which serves as the midpoint of the surgical area. For the intervention, a regimen of 0.375% ropivacaine combined with 5 mg of dexamethasone is administered in a volume of 20 ml on each side (bilateral), ensuring a dome-shaped distribution is visible both cranially and caudally beneath the erector spinae muscle.
DRUG	Bilateral ESPB: Ropivacaine 0.375%	Initial identification is performed using ultrasound (USG) guidance. Once the erector spinae muscle and the transverse process are clearly visualized, local anesthetic infiltration is administered with 1-2 ml of 2% lidocaine. A Stimuplex needle is then inserted in a cranio-caudal direction deep into the erector spinae muscle using an in-plane approach, making contact with the lateral edge of the transverse process, which serves as the midpoint of the surgical area. A regimen of 0.375% ropivacaine in a volume of 20 ml is administered on each side (bilateral) until a dome-shaped drug distribution is visualized cranially and caudally beneath the erector spinae muscle

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-08-25
• Completion: 2025-09-01
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Indonesia