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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029467
• Other study ID #: LAUMCRH.YJ1.16/Jul/2019
• Status: Recruiting
• Phase: Phase 4
• Start date: July 17, 2019
• Est. completion date: January 17, 2022

Study information

• Verified date: February 2021
• Source: Lebanese American University
• Contact: Yara Al Jalbout, MD
• Phone: +9611200800
• Email: yara.aljalbout[@]lau.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: January 17, 2022
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Axillary Lymph Node Dissection
• Breast Cancer
• Mastectomy
• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine
addition of dexmedetomidine to ropivacaine as an adjuvant in ESP block to assess wether or not it prolongs its duration of action

Locations

Country	Name	City	State
Lebanon	Lebanese American University Medical Center-Rizk Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Lebanese American University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours