search
Back to results

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

Primary Purpose

Erector Spinae Plane Block

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Use Bupivacaine 0.25% Injectable Solution
Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erector Spinae Plane Block

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Medicine Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients receiving Block with Bupivacaine only

Patients receiving Block using Bupivacaine with Dexmedetomidine

Arm Description

consists of patients receiving erector spinae plane block with Bupivacaine only

consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine

Outcomes

Primary Outcome Measures

The primary outcome will be the first time to request rescue analgesia.
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).
The primary outcome will be the first time to request rescue analgesia
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.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
August 31, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT06022614
Brief Title
Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management
Official Title
Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erector Spinae Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients receiving Block with Bupivacaine only
Arm Type
Active Comparator
Arm Description
consists of patients receiving erector spinae plane block with Bupivacaine only
Arm Title
Patients receiving Block using Bupivacaine with Dexmedetomidine
Arm Type
Active Comparator
Arm Description
consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Use Bupivacaine 0.25% Injectable Solution
Intervention Description
Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
Intervention Description
Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine
Primary Outcome Measure Information:
Title
The primary outcome will be the first time to request rescue analgesia.
Description
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).
Time Frame
From the end of the surgery till 24 hours
Title
The primary outcome will be the first time to request rescue analgesia
Description
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.
Time Frame
From the end of the surgery till 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abanoub Habib, PHD
Phone
01283575659
Email
abanoubmoureshabib@gmail.com
Facility Information:
Facility Name
Faculty of Medicine Ain Shams University
City
Cairo
ZIP/Postal Code
1181
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abanoub Habib, PHD
Phone
01283575659
Email
Abanoubmoureshabib@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs