Clinical trial · Interventional
Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery
Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study
NCT04056676CI-TRIAL-00051948unknownN/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)
To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GA with ETT | Procedure | — | UNRESOLVED |
| Intraoperative modified PEC block | Procedure | — | UNRESOLVED |
| Thoracic paravertebral block under ultrasound guidance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intraoperative modified PEC block only
- description
- Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon
- interventionNames
- Procedure: Intraoperative modified PEC block
- Procedure: GA with ETT
- type
- EXPERIMENTAL
- label
- Adding preoperative thoracic paravertebral nerve block
- description
- Preoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon
- interventionNames
- Procedure: Thoracic paravertebral block under ultrasound guidance
- Procedure: Intraoperative modified PEC block
- Procedure: GA with ETT
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * American Society of Anesthesiologists (ASA) grade I-III * Aged ≥ 18-80 years old * Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection Exclusion Criteria: * Patient refusal * Language barrier or inability to communicate with the operating team * Allergy to local anesthetic * Bleeding disorder * Previous breast surgery or thoracic radiation therapy * BMI ≥ 30 * Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication * Chronic pain patient
References
Publications (7)
- BACKGROUNDMissair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001. PMID 30640648
- BACKGROUNDWoodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641. PMID 28820803
- BACKGROUNDWynne R, Lui N, Tytler K, Koffsovitz C, Kirwa V, Riedel B, Ryan S. The Trajectory of Postoperative Pain Following Mastectomy with and without Paravertebral Block. Pain Manag Nurs. 2017 Aug;18(4):234-242. doi: 10.1016/j.pmn.2017.03.003. Epub 2017 Jun 7. PMID 28601480
- BACKGROUNDSyal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17. PMID 28890559
- BACKGROUNDTerkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80. PMID 26431130
- BACKGROUNDKlein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026. PMID 10825328
- BACKGROUNDBashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.