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

Phase 4

Recruiting

• Conditions: Spine Disease; Spinal Stenosis; Erector Spinae Plane Block; Spinal Fusion
• Interventions: Drug: 0.9% Sodium Chloride Injection; Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Dexmedetomidine injection

• Registration Number: NCT06233617
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Study Start: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	0.9% Sodium Chloride Injection	0.2% ropivacaine for erector spinae plane block
Dexamethasone	Dexamethasone 4 Mg/mL Injectable Solution	0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Dexmedetomidine	Dexmedetomidine injection	0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block

Primary Outcome Measures

Name	Time	Method
first need of opiate	48 hours	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	48 hours	Total opiate consumption after surgery
Numerical Rating Scale [range 0:10]	Time Frame: 24 hours after surgery	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
NLR	48 hours after surgery	Neutrophil-to-lymphocyte ratio
PLR	48 hours after surgery	Platelet-to-lymphocyte ratio

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland