Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

Not Applicable

Recruiting

• Conditions: Spine Disease; Spinal Diseases
• Interventions: Drug: 0.9%NaCl; Drug: Dexamethasone 4mg; Drug: Dexmedetomidine

• Registration Number: NCT07180940
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.

Detailed Description

All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used.

The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block.

This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adults aged 18 to N/A (no limit)
• Scheduled for elective lumbar spine surgery (e.g., decompression or fusion) via posterior approach
• American Society of Anesthesiologists (ASA) physical status I-III
• Body weight ≥ 50 kg
• Ability to provide written informed consent
• Expected postoperative hospitalization of at least 48 hours

Exclusion Criteria

• Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine
• Infection at or near the site of block placement
• Coagulation disorders or current use of anticoagulant therapy (not discontinued per guidelines)
• Chronic opioid use or opioid dependence
• Neurological or psychiatric disorders interfering with pain assessment
• Diabetes mellitus with poorly controlled glycemia (e.g., HbA1c > 8%)
• Severe hepatic or renal dysfunction
• Body mass index (BMI) > 40 kg/m²
• Pregnancy or breastfeeding
• Refusal or inability to cooperate with the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	0.9%NaCl	Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl)
Dexamethasone group	Dexamethasone 4mg	Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone)
Dexmedetomidine group	Dexmedetomidine	Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine)

Primary Outcome Measures

Name	Time	Method
Total opioid Consuption	48 hours after surgery	Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)

Secondary Outcome Measures

Name	Time	Method
NRS	48 hours after surgery	Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)
Nerve injury	48 hours after surgery	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
adverce effects	48 hours after surgery	nausea, vomitting, bradycardia, hypotension
Time to first rescue analgesia	48 hours after surgery	Time after surgery when the patient needs rescue analgesia for the first time
blood glucose	48 hours after surgery	Blood glucose concentration measured postoperatively
NLR - Neutrophil-to-Lymphocyte Ratio	48 hours after surgery	NLR will be calculated from complete blood count results
PLR - Platelet-to-Lymphocyte Ratio	48 hours after surgery	PLR will be calculated from complete blood count results

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland