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

NCT ID: NCT07180940

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Spine Disease Spinal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl)

Group Type PLACEBO_COMPARATOR

0.9%NaCl

Intervention Type DRUG

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

Dexamethasone group

Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone)

Group Type EXPERIMENTAL

Dexamethasone 4mg

Intervention Type DRUG

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

Dexmedetomidine group

Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine)

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Interventions

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0.9%NaCl

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

Intervention Type DRUG

Dexamethasone 4mg

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

Intervention Type DRUG

Dexmedetomidine

2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Malgorzata Reysner, M.D. Ph.D.

Role: CONTACT

+48 61 873 83 03

Facility Contacts

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Malgorzata Reysner, M.D. Ph.D.

Role: primary

+48 61 873 83 03

Other Identifiers

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01/2025

Identifier Type: -

Identifier Source: org_study_id

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