Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management

October 1, 2024 updated by: Abanoub Habib

Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management

The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.

Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries.

Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime.

Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries.

Erector spinae plane block is a newer interfascial plane block first described in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations.

Later studies have shown that ESPB can provide effective analgesia in breast surgeries.

ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.

Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical structure of target tissues, it can help to guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications .

Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
      • Cairo, Egypt, 1181
        • Faculty of medicine ain shams university

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

Yes

Description

Inclusion Criteria:

  • Age:30-65years.
  • Physical status: ASA I,II.
  • BMI<35.
  • Localized breast cancer

Exclusion Criteria:

  • Age:<30 and >65 years.
  • Refusal of procedure or participation in the study by the patient.
  • Physical status: ASA III or above.
  • History of allergy to the study drug.
  • BMI>35.
  • Bleeding disorders and coagulopathy.
  • Psychiatric illness that may interfere with the study.
  • Metastatic breast cancer.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients receiving Block with Bupivacaine only
consists of patients receiving erector spinae plane block with Bupivacaine only
Drug: Use Bupivacaine 0.25% Injectable Solution
Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
Active Comparator: Patients receiving Block using Bupivacaine with Dexmedetomidine
consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine
Drug: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be the first time to request rescue analgesia.
Time Frame: From the end of the surgery till 24 hours
The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).
From the end of the surgery till 24 hours
The primary outcome will be the first time to request rescue analgesia
Time Frame: From the end of the surgery till 24 hours
B) patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.
From the end of the surgery till 24 hours

Collaborators and Investigators

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

Sponsor

Abanoub Habib

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)

August 15, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erector Spinae Plane Block

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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