Clinical Trials Logo

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04029467
Study type Interventional
Source Lebanese American University
Contact Yara Al Jalbout, MD
Phone +9611200800
Email yara.aljalbout@lau.edu.lb
Status Recruiting
Phase Phase 4
Start date July 17, 2019
Completion date January 17, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A