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

P

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

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

Trial contacts and locations

1

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Central trial contact

Malgorzata Domagalska, PhD; Malgorzata Domagalska, PhD

Data sourced from clinicaltrials.gov

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