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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Stenosis; Erector Spinae Plane Block; Spinal Fusion; Spine Disease
• Intervention / Treatment: Drug: 0.9% Sodium Chloride Injection; Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Dexmedetomidine injection

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 (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Malgorzata Domagalska, PhD; Phone Number: +48 61 873 83 03; Email: m.domagalska@icloud.com
• Study Contact Backup: Name: Malgorzata Domagalska, PhD; Phone Number: 608762068; Email: m.domagalska@icloud.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases; Spinal Stenosis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexamethasone; Dexmedetomidine
• 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