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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233617
• Other study ID #: 3/2024
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, PhD
• Phone: +48 61 873 83 03
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Spinal Diseases
• Spinal Fusion
• Spinal Stenosis
• Spine Disease

Intervention

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
• Dexamethasone 4 Mg/mL Injectable Solution
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
• Dexmedetomidine injection
biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
Secondary	Opioid consumption	Total opiate consumption after surgery	48 hours
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	Time Frame: 4 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	Time Frame: 8 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	Time Frame: 12 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	Time Frame: 16 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	Time Frame: 20 hours after surgery
Secondary	Numerical Rating Scale [range 0:10]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)	Time Frame: 24 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	48 hours after surgery
Secondary	PLR	Platelet-to-lymphocyte ratio	48 hours after surgery