Clinical trial · Interventional
Opioid Free Anesthesia in Breast Cancer Surgery
Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study
NCT04390698CI-TRIAL-00057558completedN/AClinicalTrials.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)
A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid Free Anesthesia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| opioid free anesthesia | Drug | — | UNRESOLVED |
| opioid general anesthesia | Procedure | — | UNRESOLVED |
| paravertebral block | Procedure | — | UNRESOLVED |
| sham block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- nerve block+opioid-free general anesthesia
- description
- Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia
- interventionNames
- Procedure: paravertebral block
- Drug: opioid free anesthesia
- type
- SHAM_COMPARATOR
- label
- sham bock+opioid general anesthesia
- description
- Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia
- interventionNames
- Procedure: sham block
- Procedure: opioid general anesthesia
Primary outcomes (1)
- measure
- quality of recovery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes; 2. ASA physical statue I-II; Exclusion Criteria: 1. chronic pain and opioid administration history; 2. allergy to local anesthetics or NSAIDs; 3. coagulation disorders; 4. local infection at regional block site; 5. unable to comply to study protocol schedule for logistic or other reasons; 6. refusal to participate to the study; 7. breast reconstruction with implants or latissimus dorsi flap
References
Publications (2)
- RESULTTripathy S, Rath S, Agrawal S, Rao PB, Panda A, Mishra TS, Nayak S. Opioid-free anesthesia for breast cancer surgery: An observational study. J Anaesthesiol Clin Pharmacol. 2018 Jan-Mar;34(1):35-40. doi: 10.4103/joacp.JOACP_143_17. PMID 29643620
- DERIVEDZhang Q, Wu Y, An H, Feng Y. Postoperative recovery after breast cancer surgery: A randomised controlled trial of opioid-based versus opioid-free anaesthesia with thoracic paravertebral block. Eur J Anaesthesiol. 2023 Aug 1;40(8):552-559. doi: 10.1097/EJA.0000000000001856. Epub 2023 May 23. PMID 37218631