Skip to main content
OpenTrials
Completed

NCT Number: NCT06233617

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

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% sodium chloride injection

Drug

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.

Dexamethasone 4 Mg/mL Injectable Solution

Drug

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

Dexmedetomidine Injection

Drug

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

Primary outcomes

  1. first need of opiate

    Time frame: 48 hours

    Time after surgery when the patient needs opiate for the first time

Secondary outcomes

  1. Opioid consumption

    Time frame: 48 hours

    Total opiate consumption after surgery

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. NLR

    Time frame: 48 hours after surgery

    Neutrophil-to-lymphocyte ratio

  9. PLR

    Time frame: 48 hours after surgery

    Platelet-to-lymphocyte ratio

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.