Clinical trial NCT06233617: Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
Official title: Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Spinal Fusion
Spine Disease
Spinal Stenosis
Erector Spinae Plane Block
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: first need of opiate
timeFrame: 48 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 16 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 20 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: Time Frame: 24 hours after surgery
measure: NLR
timeFrame: 48 hours after surgery
measure: PLR
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Sciences
name: Malgorzata Domagalska, PhD
role: PRINCIPAL_INVESTIGATOR
References: