Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery

May 6, 2026 updated by: Poznan University of Medical Sciences
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.

After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Poznań
      • Poznan, Poznań, Poland, 61-701
        • Poznan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,
  • aged >18 years and <100 years
  • ASA physical status 1, 2 or 3.

Exclusion Criteria:

  • refuse to participate,
  • history of opioid abuse,
  • infection of the puncture site,
  • aged <18 years and >100 years
  • ASA 4 and 5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
0.2% ropivacaine for erector spinae plane block
Drug: 0.9% Sodium Chloride Injection
biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
Other Names:
  • 0.9% Sodium Chloride iv.
Active Comparator: Dexamethasone
0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Drug: Dexamethasone 4 Mg/mL Injectable Solution
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
Other Names:
  • 0,2% ropivacaine with 4mg Dexamethasone iv
Active Comparator: Dexmedetomidine
0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
Drug: Dexmedetomidine injection
biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
Other Names:
  • 0,2% ropivacaine with 50ug Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first need of opiate
Time Frame: 48 hours
Time after surgery when the patient needs opiate for the first time
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 48 hours
Total opiate consumption after surgery
48 hours
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 4 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 8 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 12 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 16 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame: 16 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 20 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: Time Frame: 24 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame: 24 hours after surgery
NLR
Time Frame: 48 hours after surgery
Neutrophil-to-lymphocyte ratio
48 hours after surgery
PLR
Time Frame: 48 hours after surgery
Platelet-to-lymphocyte ratio
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Malgorzata Domagalska, PhD, Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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