N/A
Completed N=129
Reducing Pain and Disability After Breast Cancer Surgery
Source: ClinicalTrials.gov NCT01089933 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection. — 5; 4 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection. |
5; 4 | — |
| SECONDARY Arm Morbidity, Shoulder Range of Motion, Quality of Analgesia, Arm Lymphedema, Time to Meet Discharge Criteria, Quality of Recovery, Quality of Life, Incidence of Postoperative Side Effects. |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01089933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.