Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain

February 18, 2024 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain

Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

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:

  • Age from 18 to 65 years.
  • Male and female sexes.
  • ASA I-II.,III
  • Cancer patients undergoing thoracotomy incisions
  • Body mass index (BMI) from 18.5 to 30 kg/m2

Exclusion Criteria:

  • Patient refusal
  • Known allergy to any of the used drugs
  • Low platelet count, any coagulation defect

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: Erector spinae plane block with 0.25% bupivacaine
Patients will receive ultrasound guided ESPB with 0.25% bupivacaine
Drug: Bupivacaine
Bupivacaine 0.25%
Experimental: Erector spinae plane block with 0.25% bupivacaine and Magnesium
Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium
Drug: Bupivacaine + Magnesium
Bupivacaine 0.25% + Magnesium
Experimental: Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine
Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine
Drug: Bupivacaine + Dexmedetomidine
Bupivacaine 0.25% + Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative morphine consumption
Time Frame: First 24 hours postoperatively
Total dose of morphine needed postoperatively in the first 24 h
First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first postoperative rescue analgesia.
Time Frame: First 24 hours postoperatively
Time to first postoperative rescue analgesia.
First 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Walaa Y Elsabeeny, MD, Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
  • Study Director: Ahmed A Mohamed, MD, Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine

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)

May 15, 2023

Primary Completion (Estimated)

March 25, 2024

Study Completion (Estimated)

April 27, 2024

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-80-2022/NSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Information is available upon reasonable request through contacting the corresponding investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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