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

NCT ID: NCT06233617

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Fusion Spine Disease Spinal Stenosis Erector Spinae Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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placebo

0.2% ropivacaine for erector spinae plane block

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type DRUG

biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block

Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone 4 Mg/mL Injectable Solution

Intervention Type DRUG

biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine injection

Intervention Type DRUG

biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Interventions

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0.9% Sodium Chloride Injection

biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block

Intervention Type DRUG

Dexamethasone 4 Mg/mL Injectable Solution

biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block

Intervention Type DRUG

Dexmedetomidine injection

biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Intervention Type DRUG

Other Intervention Names

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0.9% Sodium Chloride iv. 0,2% ropivacaine with 4mg Dexamethasone iv 0,2% ropivacaine with 50ug Dexmedetomidine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malgorzata Domagalska, PhD

Role: PRINCIPAL_INVESTIGATOR

Poznań University of Medical Sciences

Locations

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Poznan University of Medical Sciences

Poznan, Poznań, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Malgorzata Domagalska, PhD

Role: CONTACT

+48 61 873 83 03

Malgorzata Domagalska, PhD

Role: CONTACT

608762068

Facility Contacts

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Malgorzata Domagalska, Ph.D.

Role: primary

608762068

Other Identifiers

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3/2024

Identifier Type: -

Identifier Source: org_study_id

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