Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries

February 21, 2023 updated by: Anwar ul Huda, Security Forces Hospital

Efficacy of Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries - A Randomised Controlled Trial

The aim of this study is to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block in reducing opioid consumption for patients undergoing lumbar spine surgeries. This study will help in understanding the role of adding dexmdetomidine to ropivacaine in erector spinae block in reducing opioid consumption after lumbar spine surgeries

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A number of adjuvants have been used with local anesthetics including dexamethasone, nalbuphine and dexmedetomidine etc with the aim of improving quality and duration of peripheral nerve blocks. Dexmedetomidine is a potent alpha-2 agonist which can prolong the duration of regional anesthesia block when used in combination with local anesthetics. Although, there is no consensus on the dose of dexmedetomidine for peripheral nerve block considering the fact that it can lower heart rate and blood pressure intraoperatively. Investigators therefore, planned this randomised controlled trial to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block for patients undergoing lumbar spine surgeries.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 4

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 Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Recruiting
        • Security Forces Hospital
        • Contact:
          • Anwar ul huda, FRCA
          • Phone Number: 0502654719

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 18 and 70 years, scheduled to undergo lumbar spine surgeries with an ASA score of 1 to 3 will be included in the study

Exclusion Criteria:

  • Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics or dexmedetomidine, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications will not be included in the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESPB group
this group will receive ESPB using ropivacaine and dexmedetomidine
Other: ESPB (regional Block)
ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine
Drug: ropivacaine and dexmedetomidine
0.2 % ropivacaine and dexmedetomidine
No Intervention: Control group
this group will not receive any block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hours opioid consumption
Time Frame: 24 hours
opioid consumption in mg during first 4 hours postoperatively
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 24 hours
pain score in Numerical rating score during first 24 hours postoperatively
24 hours
Occurrence of postoperative nausea and vomiting (PONV)
Time Frame: 24 hours
Occurrence of postoperative nausea and vomiting (PONV) during first 24 hours
24 hours
Occurrence of drowsiness
Time Frame: 24 hours
Occurrence of drowsiness in 24 hours will be recorded
24 hours

Collaborators and Investigators

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

Sponsor

Security Forces Hospital

Investigators

  • Principal Investigator: Anwar ul Huda, FRCA, Security Forces Hospital

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 (Actual)

December 15, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFH-ESPB Dex

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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