Clinical trial · Interventional
Reducing Pain and Disability After Breast Cancer Surgery
Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection
NCT01089933CI-TRIAL-00088130RELIeFcompletedN/AResults postedClinicalTrials.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)
The purpose of this study is to determine if the combination of thoracic paravertebral block and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing breast cancer surgery with lymph node dissection as compared to patients receiving local anesthesia with multimodal analgesia.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Anesthetic | Procedure | — | UNRESOLVED |
| Thoracic Paravertebral Block (TPVB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thoracic PVB + multimodal anesthesia
- description
- Thoracic PVB + multimodal anesthesia
- interventionNames
- Procedure: Thoracic Paravertebral Block (TPVB)
- type
- ACTIVE_COMPARATOR
- label
- Local anesthetic + multi-modal analgesia
- description
- Local anesthetic + multi-modal analgesia
- interventionNames
- Procedure: Local Anesthetic
Primary outcomes (1)
- measure
- The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of breast cancer * Scheduled for elective modified radical mastectomy, simple mastectomy with SLNB, breast conserving surgery (ie lumpectomy, segmental mastectomy) with ALND or ALND alone (after positive SLNB) Exclusion Criteria: * American Society of Anesthesiologist (ASA) class 4 or 5 * Patients with contraindications to TPVB * Allergy to study medications * Chronic opioid use defined as daily consumption of greater than 20 mg of oral morphine or equivalent for \>7days * Renal insufficiency defined as a creatinine clearance \<40ml/min as calculated using the Cockroft-Gault formula * Preoperative radiation therapy * Inability to achieve normal shoulder range of motion as defined as \<100o of shoulder abduction or flexion
References
Publications (1)
- RESULTChiu M, Bryson GL, Lui A, Watters JM, Taljaard M, Nathan HJ. Reducing persistent postoperative pain and disability 1 year after breast cancer surgery: a randomized, controlled trial comparing thoracic paravertebral block to local anesthetic infiltration. Ann Surg Oncol. 2014 Mar;21(3):795-801. doi: 10.1245/s10434-013-3334-6. Epub 2013 Oct 29. PMID 24165901