Clinical trial · Interventional
Speeding Recovery From Pain and Opioid Use
Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Funding
Summary
Brief summary (as posted)
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. However, breast reconstruction at the same time as mastectomy has been linked to higher postoperative pain, which can be a risk factor for persistent pain. The goal of this study is to determine the speed of recovery from pain and opioid use in the first 2 months after breast surgery and reconstruction.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Opioid Use | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local infiltration of bupivacaine | Drug | — | UNRESOLVED |
| Pectoralis Nerve block | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine Group
- description
- Those patients randomized to surgeon infiltration will have a skin wheal performed with lidocaine at the site where an actual pectoralis nerve block would be performed as visualized using ultrasound. Surgeons performing infiltration techniques will be blinded to the contents of the injectate and those patients randomized to surgeon infiltration will receive pharmacy study drug labeled bupivacaine injected in the same fashion and volume as the saline group for oncologic and plastic surgery.
- interventionNames
- Drug: Local infiltration of bupivacaine
- type
- EXPERIMENTAL
- label
- Pectoralis Nerve block Group
- description
- Those patients who are randomized to pectoralis nerve block will have randomization immediately preoperatively and will undergo the nerve block procedure using local anesthetic in the standard fashion. Those patients randomized to pectoralis block will have a standard volume of normal saline injected for oncologic and plastic surgery.
- interventionNames
- Drug: Pectoralis Nerve block
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for unilateral mastectomy with immediate issue expander and implant based reconstruction. * Age ≥ 18 years * Ability to understand, read, and write English, and the willingness to sign an IRB-approved informed consent document. * Patients who receive a tissue expander placement will be included in the study. * American Society of Anesthesiologists physical status I-III patients. Exclusion Criteria: * Patients who receive an autologous tissue reconstruction. * Patients who receive a bilateral reconstruction. * Patients who receive a direct to permanent implant reconstruction * Patients with diagnosis of opioid misuse disorder or on high dose opioid therapy (greater than 100 mg equivalents of oral morphine per day) * Patients who are wards of the state * Patients who cannot read or speak English * History of allergic reactions attributed to compounds with known or suspected cross-sensitivity to bupivacaine. * Pregnant or breast feeding * Inability to access to the internet on a daily basis
References
Publications (0)
Data not yet available