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Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery

Primary Purpose

Breast Cancer, Mastectomy, Axillary Lymph Node Dissection

Status
Unknown status
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring ESP block, erector spinae plane block, mastectomy, ropivacaine, dexmedetomidine, pain, breast

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA class I, II and III patients
  2. Age range: 18-80 years old
  3. Elective partial or unilateral radical mastectomy with sentinel lymph node dissection

Exclusion Criteria:

  1. Pregnant woman
  2. Bilateral mastectomy.
  3. Skin infection at the site of needle puncture
  4. Coagulopathy problems
  5. Allergy or contraindication to any of the study drugs
  6. Recent use of opioid drugs

Sites / Locations

  • Lebanese American University Medical Center-Rizk HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Precedex

Dexmedetomidine

Arm Description

participants will receive an ESP block with 20 ml Ropivacaine 0.375% in the induction room 20 minutes before their operation

participants will receive an ESP block with 20 ml Ropivacaine 0.375% + 0.5mcg/kg dexmedetomidine in the induction room 20 minutes before their operation

Outcomes

Primary Outcome Measures

Pain assessment in the first 24 hours post operatively: VAS score
Pain will be assessed using the VAS score ranging from 0, indicating no pain at all, to 10, indicating the worst pain the patient has ever felt

Secondary Outcome Measures

Full Information

First Posted
July 17, 2019
Last Updated
February 20, 2021
Sponsor
Lebanese American University
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1. Study Identification

Unique Protocol Identification Number
NCT04029467
Brief Title
Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery
Official Title
Addition of Dexmedetomidine to Ropivacaine for Ultrasound Guided Erector Spinae Block: Evaluation of Effect on Postoperative Pain After Breast Surgery: A Double-Blinded, Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
July 17, 2021 (Anticipated)
Study Completion Date
January 17, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients undergoing Partial or total mastectomy with axillary LN dissection will receive prior to induction of general anaesthesia ESP block at T4 level at the same side of the surgery. one group will receive ropivacaine 0.375% and the other will get ropivacaine 0.375% with dexmedetomidine 0.5mcg/kg as an adjuvant. time to first narcotic requirement will be documented and therefore an assessment of the duration of action of the block will be made
Detailed Description
Background and Objective: Whether partial or complete, mastectomy with axillary lymph node dissection is a painful surgery. Acute postoperative pain management is challenging and crucial due to high chances of it transforming into chronic pain. Erector spinae plane (ESP) block has been shown to be effective in managing post mastectomy pain.Dai et al showed the effectiveness of dexmedetomidine in prolonging the duration of sensory block, motor block and analgesia when dexmedetomidine as an adjunct is added to ropivacaine in brachial plexus block (1). The aim of our study is to show the effectiveness of dexmedetomidine in prolonging the analgesic effect of ropivacaine when added to it in ESP block compared to using ropivacaine alone in patients undergoing mastectomy with axillary lymph node dissection, and to study its impact on postoperative opioid consumption. Methods: 44 American Society of Anesthesiologist (ASA) physical status classification class I, II and III will be randomly allocated to one of two groups, both receiving a single injection erector spinae plane block at T4 vertebral level using 20ml ropivacaine 0.375% 20 minutes before the induction of anesthesia. The first group will receive 0.5mcg/kg of dexmedetomdine added to the ropivacaine solution. The control group will receive no dexmedetomidine. Postoperatively, patients in both groups will be receive acetaminophen 1g orally every 6 hours and oxycodone 5 mg orally as needed every 6 hours if VAS is more than 4. Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours. Conclusion: This study will be the first of its kind to investigate the impact of adding dexmedetomidine as an adjunct to ropivacaine in prolonging the ESP block duration in patients undergoing mastectomy with axillary lymph node dissection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Mastectomy, Axillary Lymph Node Dissection, Pain, Postoperative
Keywords
ESP block, erector spinae plane block, mastectomy, ropivacaine, dexmedetomidine, pain, breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Precedex
Arm Type
Active Comparator
Arm Description
participants will receive an ESP block with 20 ml Ropivacaine 0.375% in the induction room 20 minutes before their operation
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
participants will receive an ESP block with 20 ml Ropivacaine 0.375% + 0.5mcg/kg dexmedetomidine in the induction room 20 minutes before their operation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
addition of dexmedetomidine to ropivacaine as an adjuvant in ESP block to assess wether or not it prolongs its duration of action
Primary Outcome Measure Information:
Title
Pain assessment in the first 24 hours post operatively: VAS score
Description
Pain will be assessed using the VAS score ranging from 0, indicating no pain at all, to 10, indicating the worst pain the patient has ever felt
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Biologically female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA class I, II and III patients Age range: 18-80 years old Elective partial or unilateral radical mastectomy with sentinel lymph node dissection Exclusion Criteria: Pregnant woman Bilateral mastectomy. Skin infection at the site of needle puncture Coagulopathy problems Allergy or contraindication to any of the study drugs Recent use of opioid drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yara Al Jalbout, MD
Phone
+9611200800
Ext
5226
Email
yara.aljalbout@lau.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Hanane Barakat, MD
Phone
+9611200800
Ext
5226
Email
hanane.barakat@laumcrh.com
Facility Information:
Facility Name
Lebanese American University Medical Center-Rizk Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Rizk
Phone
+9611200800
Ext
6035
Email
sami.rizk@laumcrh.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery

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