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

NCT ID: NCT04029467

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2022-01-17

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Precedex

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Dexmedetomidine

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lebanese American University

OTHER

Sponsor Role: lead

Responsible Party

Yara Al Jalbout

Clinical Instructor, Director Anaesthesiology Residency Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lebanese American University Medical Center-Rizk Hospital

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Yara Al Jalbout, MD

Role: CONTACT

yara.aljalbout@lau.edu.lb

+9611200800 ext. 5226

Hanane Barakat, MD

Role: CONTACT

hanane.barakat@laumcrh.com

+9611200800 ext. 5226

Facility Contacts

Sami Rizk

Role: primary

sami.rizk@laumcrh.com

+9611200800 ext. 6035

Other Identifiers

LAUMCRH.YJ1.16/Jul/2019

Identifier Type: -

Identifier Source: org_study_id