BUPIVACAINE for Breast cancer|Postoperative pain

Inclusion criteria

• {"criterion_text":"- Unilateral mastectomy.\n- Written informed consent according to ICH/GCP and national regulations.\n- ASA (American Society of Anesthesiologists) Class I-III."}

Exclusion criteria

• {"criterion_text":"- Patients < 18 year old.\n- Bilateral surgery.\n- Bleeding disorder or coagulopathy.\n- Chest wall deformity or infection of injection site.\n- Another (additional) nerve block (such as TPVB or epidural anesthesia).\n- Autologous or implant based breast reconstruction.\n- Known allergy for (levo)bupivacaine or local anesthetics from the amide group.\n- Known allergy or contra-indication for NSAID.\n- Chronic use of opiates preoperatively (> 12 weeks).\n- Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).\n- Not able to speak or understand the Dutch language fluently.\n- Palliative surgery.\n- Metastatic disease.\n- Pregnancy or breast feeding.\n- Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol"}

Primary endpoints

• {"endpoint_text":"- Postoperative NRS pain scores in the breast.","definition_or_measurement_approach":"Numeric Rating Scale (NRS) pain scores in the breast (NRS as reported in trial documents)."}

Secondary endpoints

• {"endpoint_text":"- Postoperative NRS pain scores in the axilla.","definition_or_measurement_approach":"Numeric Rating Scale (NRS) pain scores in the axilla."}
• {"endpoint_text":"- Intraoperative need of opiates (milligrams).","definition_or_measurement_approach":"Measured as total intraoperative opioid consumption in milligrams."}
• {"endpoint_text":"- Postoperative need of opiates or other pain killers (milligrams).","definition_or_measurement_approach":"Measured as postoperative opioid or other analgesic consumption in milligrams."}
• {"endpoint_text":"- Patient-reported chronic (> 12 weeks) pain (yes/no).","definition_or_measurement_approach":"Patient-reported presence of chronic pain beyond 12 weeks (binary yes/no)."}
• {"endpoint_text":"- Patient satisfaction, measured by the BREAST-Q BCT.","definition_or_measurement_approach":"Measured using the BREAST-Q BCT patient satisfaction instrument."}
• {"endpoint_text":"- Postoperative time that patients need to be observed in the recovery room (minutes).","definition_or_measurement_approach":"Measured as observation time in the recovery room in minutes."}
• {"endpoint_text":"- Time until patients are discharged from the hospital (hours).","definition_or_measurement_approach":"Measured as time from procedure to hospital discharge in hours."}
• {"endpoint_text":"- Use of additional anti-emetics for PONV (yes/no).","definition_or_measurement_approach":"Binary measure of whether additional anti-emetics were used for postoperative nausea and vomiting."}
• {"endpoint_text":"- Vomiting (yes/no).","definition_or_measurement_approach":"Binary measure of occurrence of postoperative vomiting (yes/no)."}
• {"endpoint_text":"- Complications (wound infection rate, hematoma, abscess, pneumothorax, local anesthesia systemic toxicity).","definition_or_measurement_approach":"Composite safety endpoint capturing specified complications (wound infection, hematoma, abscess, pneumothorax, local anesthetic systemic toxicity)."}

Netherlands

Latest Decision Or Authorization Date

18-06-2024

Number Of Sites

2

Number Of Participants

130

Primary sponsor

Full Name

St. Antonius Ziekenhuis

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands