Clinical Trials Logo
NCT number NCT03456661
Study type Interventional
Source University Hospital, Antwerp
Contact Hilde Coppejans, MD
Phone 38214786
Status Recruiting
Phase Phase 4
Start date May 19, 2014
Completion date December 2020

Clinical Trial Summary

A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure.

The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups .

Our hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be our primary outcome parameter.

Clinical Trial Description

Women (18+, American Society of Anesthesiologists 1,2,3) undergoing a mastectomy with axillar procedure will be randomised and receive a ultrasound guided modified pectoral nerve block if they meet in and exclusion criteria and provide written informed consent.

Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.

Every patient receives intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).

Furthermore every patient in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.

When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthetist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).

Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults N/A
Recruiting NCT03284957 - Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer Phase 1/Phase 2
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Active, not recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Recruiting NCT03432429 - REI-EXCISE iKnife Study N/A
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT03323333 - Psychosocial Intervention Pilot for Partners in BRCA Testing N/A
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Not yet recruiting NCT03433313 - Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer Phase 3
Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
Not yet recruiting NCT03273348 - Role of Oncoplastic Breast Surgery In Breast Cancer Treatement N/A
Active, not recruiting NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Recruiting NCT03324932 - Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer Phase 3
Recruiting NCT03237572 - Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer Phase 1
Recruiting NCT02125019 - Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer N/A