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

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Erector Spinae Plane Block; Spine Disease; Spinal Stenosis; Spinal Fusion

Treatments: Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Dexmedetomidine injection; Drug: 0.9% Sodium Chloride Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06233617

3/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

0.2% ropivacaine for erector spinae plane block

Treatment:

Drug: 0.9% Sodium Chloride Injection

Dexamethasone

Active Comparator group

Description:

0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block

Treatment:

Drug: Dexamethasone 4 Mg/mL Injectable Solution

Dexmedetomidine

Active Comparator group

Description:

0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block

Treatment:

Drug: Dexmedetomidine injection