Clinical trial · Interventional
Regional Anesthesia in Breast Surgery
Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is a trend that breast surgery can be done with peripheral nerve blockade and intravenous sedation, which reduces the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex. Common nerve block methods are paravertebral blocks and pectoral nerve blocks. By monitoring the patient's heart rate variability change and measuring the patient's parasympathetic tone, the analgesic drug can be administered according to the patient's individual differences to avoid insufficient or excessive analgesic dose. The aim of this proposal is a prospective randomized controlled clinical trial is designed to evaluate changes in analgesia nociception index (ANI), surgical pleth index (SPI), postoperative opioid demand, and pain scores between patients who received regional anesthesia and those without in breast surgery patients under non-intubated surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pain | — | UNRESOLVED | — |
| Regional Anesthesia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regional anesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regional anesthesia
- description
- Regional block applied according to surgical area
- interventionNames
- Procedure: Regional anesthesia
- type
- NO_INTERVENTION
- label
- No Regional anesthesia
- description
- No regional anesthesia applied
Primary outcomes (7)
- measure
- Post-operative opioid use
- timeFrame
- From start of post operative care unit to discharge from post operative care unit, up to two hours
- description
- Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Breast neoplasm require surgical resection of tumor * Surgical type: non-intubated breast surgery under intravenous anesthesia Exclusion Criteria: * Contraindication for regional anesthesia: coagulopathy, infection * Previous breast surgery * Body mass index \> 40 * Chronic opioid use * Allergy to intravenous and regional anesthesia agents: Propofol, remifentanil, bupivacaine
References
Publications (0)
Data not yet available