Dexamethasone as ESPB Adjuvant in Lumbar Laminectomy

NCT07429708 | Completed Phase 3 DMC

• 1 other identifier: 0326/UN14.2.2.VII.14/LT/2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Dexamethasone; Erector Spinae Plane Block; Laminectomy; Prostaglandin E2

Outcome Measures

Primary Outcomes (4)

• Duration of Analgesia

  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.

  From the completion of the ESP block until the first request for rescue analgesia (assessed up to 24 hours post-surgery)

• Postoperative increase in PGE2 levels

  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)

  PGE2 Levels Preoperatively (baseline) and 24 hours after surgery

• Postoperative VAS pain scores at 8, 12, 16, and 24 hours

  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.

  8, 12, 16, and 24 hours after the surgery done

• Postoperative PCA Fentanyl requirements

  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

  8, 12, 16, and 24 hours after surgery

Study Arms (2)

ESPB With Dexamethasone

EXPERIMENTAL

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

Drug: Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg

ESPB Without Dexamethasone

ACTIVE COMPARATOR

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

Drug: Bilateral ESPB: Ropivacaine 0.375%

Interventions

Bilateral ESPB: Ropivacaine 0.375% + Dexamethasone 5mg DRUG

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.

ESPB With Dexamethasone

Bilateral ESPB: Ropivacaine 0.375% DRUG

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

ESPB Without Dexamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 - 65 years
• ASA physical status I-III
• Patients with a BMI of 18 - 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Ngoerah General Hospital

Denpasar, Bali, 80113, Indonesia

Location

Related Publications (2)

• Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.

  PMID: 16236742 RESULT

• Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.

  PMID: 30640652 RESULT

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: "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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Resident of Anesthesiology and Intensive Care Therapy

Model Details: This study evaluates the effectiveness of adding dexamethasone as an adjuvant to the Bilateral Erector Spinae Plane (ESP) block for patients undergoing lumbar laminectomy surgery. While the ESP block is a common method for pain relief, its duration is often limited when used alone. The researchers aim to determine if dexamethasone can prolong the duration of pain relief, improve the overall quality of analgesia, and reduce the body's inflammatory response by measuring Prostaglandin E2 (PGE2) levels. Additionally, the study investigates whether this combination reduces the amount of opioid medication (fentanyl) required by patients during the first 24 hours after surgery. Thirty-six patients were randomly assigned to receive the ESP block either with or without dexamethasone to compare these outcomes

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 24, 2026
• Study Start: March 10, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 1, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)