Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.

NCT ID: NCT05850468

Last Updated: 2023-05-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-11-30

Brief Summary

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opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

Detailed Description

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patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery

Conditions

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Opioid Use Spine Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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traditinal balanced anesthesia

fentanyl infusion after general anesthesia and erector spinea block

Group Type ACTIVE_COMPARATOR

fentanyl infusion after general anesthesia and erector spinea block

Intervention Type DRUG

intraoperative opioid infusion in active comparative group

opioid free anesthesia

lidocaine and dextometidine infusion after general anesthesia and erector spinea block

Group Type EXPERIMENTAL

lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block

Intervention Type DRUG

intraoperative non opioid infusion in experimental group

Interventions

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fentanyl infusion after general anesthesia and erector spinea block

intraoperative opioid infusion in active comparative group

Intervention Type DRUG

lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block

intraoperative non opioid infusion in experimental group

Intervention Type DRUG

Other Intervention Names

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opioid infusion lidocaine 2% and precedex infusion

Eligibility Criteria

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Inclusion Criteria

\- spine surgery ASAI,II

Exclusion Criteria

* revision surgery hypotension bradycardia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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sanaa wasfy, professor

Role: PRINCIPAL_INVESTIGATOR

assistant professor of anesthesia

Locations

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Ainshams hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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sanaa wasfy, professor

Role: CONTACT

01061262757

wael behairy, professor

Role: CONTACT

01282269727

References

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Rowland M, Thomson PD, Guichard A, Melmon KL. Disposition kinetics of lidocaine in normal subjects. Ann N Y Acad Sci. 1971 Jul 6;179:383-98. doi: 10.1111/j.1749-6632.1971.tb46915.x. No abstract available.

Reference Type BACKGROUND
PMID: 5285383 (View on PubMed)

Other Identifiers

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MS81/2023

Identifier Type: -

Identifier Source: org_study_id

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