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

Lebanese American University

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04029467

LAUMCRH.YJ1.16/Jul/2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Precedex

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine

Experimental group

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

Treatment:

Drug: Dexmedetomidine