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

April 29, 2023 updated by: Ain Shams University

Assistant Professor of Anesthesia, Intensive Care and Pain Management

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ainshams hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- spine surgery ASAI,II

Exclusion Criteria:

  • revision surgery hypotension bradycardia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: traditinal balanced anesthesia
fentanyl infusion after general anesthesia and erector spinea block
Drug: fentanyl infusion after general anesthesia and erector spinea block
intraoperative opioid infusion in active comparative group
Other Names:
  • opioid infusion
Experimental: opioid free anesthesia
lidocaine and dextometidine infusion after general anesthesia and erector spinea block
Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block
intraoperative non opioid infusion in experimental group
Other Names:
  • lidocaine 2% and precedex infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients (percentage) having intraoperative systolic hypertension
Time Frame: during operation(intraoperatively)
blood pressure more than 160 mmhg
during operation(intraoperatively)
number of patients(percentage) having tachycardia
Time Frame: during operation(intraoperatively)
heart rate more than 100 beat /minute
during operation(intraoperatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: every 30 minutes for 2 hours postoperatively
score from 0 to 10, 0 is no pain and 10 the worst pain
every 30 minutes for 2 hours postoperatively
incidence of bradycardia
Time Frame: intraoperatively
heart rate less than 45 beat per minute
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: sanaa wasfy, professor, assistant professor of anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

April 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS81/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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