Clinical trial · Interventional
Quality Study of Anesthetic Technique on Breast Cancer Surgery
Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery
NCT01499836CI-TRIAL-00013486PQSATcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Pain | — | UNRESOLVED | — |
| Quality of Recovery | — | UNRESOLVED | — |
| Satisfaction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PVB | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- general anesthesia and PVB
- description
- general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. After intubation, paravertebral injections will be performed under ultrasound guidance.
- interventionNames
- Other: PVB
- type
- EXPERIMENTAL
- label
- sedation and PVB
- description
- After sedation with midazolam and fentanyl, the patients in sedation and PVB group will receive PVB. paravertebral injections will be performed under ultrasound guidance.Intraoperative sedation will be provided with propofol titrated to moderate sedation.
- interventionNames
- Other: PVB
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has a physical status between ASA I and III * Female * 18 - 70 years of age * Patients able to read a newspaper in Chinese. * Elective unilateral wide excision/simple mastectomy and SLNB/ALND * Patient has signed an informed consent * Without contraindication of GA or PVB * Body mass index (BMI) less than 24 kg/m2 Exclusion Criteria: * ASA \> III * inability to provide informed consent * Bleeding disorders * Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs) * Allergy to amide-type local anesthetics or NSAIDs * Infection at the thoracic paravertebral injection site * Pregnancy or breast-feeding * Severe spine or chest wall deformity * body mass index equal to or more than 24 kg/m2 * patients with major psychosis or drug and alcohol abuse * patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease * Patients with significant visual impairment or other physical disability that precludes complete cooperation
References
Publications (0)
Data not yet available
No reference posted for this study.