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

Phase 4RecruitingNCT07180940

Poznan University of Medical Sciences150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Spine Disease Spinal Diseases

Interventions

0.9%NaClDRUG

2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl

Dexamethasone 4mgDRUG

2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone

DexmedetomidineDRUG

2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

Outcomes

Primary Outcomes

Total opioid Consuption

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

Time frame: 48 hours after surgery

Secondary Outcomes

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame: 4 hours after surgery

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame: 8 hours after surgery

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame: 12 hours after surgery

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame: 24 hours after surgery

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame: 48 hours after surgery

Nerve injury

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)

Time frame: 12 hours after surgery

Nerve injury

Time frame: 24 hours after surgery

Nerve injury

Time frame: 48 hours after surgery

adverce effects

nausea, vomitting, bradycardia, hypotension

Time frame: 48 hours after surgery

Time to first rescue analgesia

Time after surgery when the patient needs rescue analgesia for the first time

Time frame: 48 hours after surgery

blood glucose

Blood glucose concentration measured postoperatively

Time frame: 12 hours after surgery

blood glucose

Blood glucose concentration measured postoperatively

Time frame: 24 hours after surgery

blood glucose

Blood glucose concentration measured postoperatively

Time frame: 48 hours after surgery

NLR - Neutrophil-to-Lymphocyte Ratio

NLR will be calculated from complete blood count results

Time frame: 12 hours after surgery

NLR - Neutrophil-to-Lymphocyte Ratio

NLR will be calculated from complete blood count results

Time frame: 24 hours after surgery

NLR - Neutrophil-to-Lymphocyte Ratio

NLR will be calculated from complete blood count results

Time frame: 48 hours after surgery

PLR - Platelet-to-Lymphocyte Ratio

PLR will be calculated from complete blood count results

Time frame: 12 hours after surgery

PLR - Platelet-to-Lymphocyte Ratio

PLR will be calculated from complete blood count results

Time frame: 24 hours after surgery

PLR - Platelet-to-Lymphocyte Ratio

PLR will be calculated from complete blood count results

Time frame: 48 hours after surgery

Central Contacts

Malgorzata Reysner, M.D. Ph.D.

CONTACT

+48 61 873 83 03 mreysner@ump.edu.pl

Data from ClinicalTrials.gov

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