Clinical trial · Interventional
Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy
Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use Following Mastectomy
NCT04019834CI-TRIAL-00060074RELIEFcompletedEarly Phase 1ClinicalTrials.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 see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia, Local | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy | — | UNRESOLVED | — |
| Narcotic Use | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo regional nerveblock with normal saline | Other | — | UNRESOLVED |
| regional nerve block with local anesthesia of bupivacaine with steroid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- regional nerve block with local anesthesia
- description
- Treatment Arm (n=55) will receive titrated sedation with a combination of fentanyl and versed prior to the start of the block. An ultrasound will be used to identify the fascial planes and perform regional nerve blocks. A block needle will be passed into the fascial plane an injectate will be deposited . The injectate in the active arm will contain a local anesthestic and dexamethasone.
- interventionNames
- Drug: regional nerve block with local anesthesia of bupivacaine with steroid
- type
- PLACEBO_COMPARATOR
- label
- regional nerve block with normal saline
- description
- Placebo Comparator Arm (n=55). Patients will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue.
- interventionNames
- Other: Placebo regional nerveblock with normal saline
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women at least 19 years old who are able to provide written and informed consent 2. Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention 3. Patients with ASA class of I-III will be included Exclusion Criteria: 1. Stage IV breast cancer, morbid obesity with BMI \>45kg/m2 2. Renal insufficiency (Creatinine \>1.5 mg/dL) 3. Current chronic analgesic use (daily use for \> or equal to 4 weeks) 4. History of opioid abuse or dependence 5. Presence of chronic pain with a self-reported average pain score of 4 or greater on a pain scale of 0-10 prior to any surgical intervention 6. Incarceration 7. Pregnancy 8. Immediate autologous tissue reconstruction.
References
Publications (0)
Data not yet available
No reference posted for this study.