Pectoral Block in Breast Reduction for Pain Control
Purpose
A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. It is well documented in the literature that this procedure has a statistically significant reduction in patient symptoms. Postoperatively, it has been within the norm to prescribe narcotics in order to alleviate post-procedural pain. Recently, however, the research realm has advocated a non-narcotic multimodal pain control (MMPC) approach to minimize narcotic usage. Narcotic use is associated with increased costs in the healthcare system due to reported heightened pain scores for extended duration, constipation, nausea, vomiting, opiate dependence among other factors associated with increased morbidity. The goal of this study is to determine if PECs II (pectoral block type II) block alone is non-inferior to the standard multimodal pain control with narcotics for postoperative pain reduction in breast reduction.
Condition
- Macromastia (Symptomatic)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Undergoing breast reduction surgery - Women older than age 18 and under age 75 - Stable breast size for at least 1 year - Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities for at least 1 year: Headaches; Pain in neck; Pain in shoulders; Pain in upper back; Painful kyphosis documented by X-rays; Pain/discomfort/ulceration from bra straps cutting into shoulders; Skin breakdown (severe soft tissue infection, tissue necrosis, ulceration hemorrhage) from overlying breast tissue; Upper extremity parasthesia - Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs - Pain symptoms persist as documented by the physician despite at least a 3-month trial of therapeutic measures such as: Analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) interventions and/or muscle relaxants Dermatologic therapy of ulcers, necrosis and refractory infection Physical therapy/exercises/posturing maneuvers Supportive devices (e.g., proper bra support, wide bra straps) Chiropractic care or osteopathic manipulative treatment Medically supervised weight loss program Orthopedic or spine surgeon evaluation of spinal pain - Breast Reduction is likely to cause a reduction in patient symptoms - Women 50 years of age or older are required to have a mammogram that was negative for cancer performed within the two years prior to the date of the planned reduction mammoplasty - Greater than 40 kg in weight
Exclusion Criteria
- History of chronic pain controlled with prescribed narcotics - English as non-primary language - No access to email or internet - Positive pre-surgery pregnancy test - Women not of ages 18-75 - Less than 40 kg in weight
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be initially identified and introduced to the study in their preoperative breast reduction consultation in the office. Patients will be contacted via phone for the consenting process, which they will have a virtual copy of their consent, after their consultation. After completion of the consenting and enrollment process, they will be entered into REDCap and the software will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, patients are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Patients will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Patients in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness.
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
- Masking Description
- Participants are blinded in the study from which group they were randomized into. The postoperative care, surveys, and pain control regimen is standardized between the two groups. Blinding is maintained until patients complete their 1 week postoperative surveys.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Control group |
Patients receive wetting solution with lidocaine and epinephrine in both breasts at the beginning of the case for analgesia and hemostasis. No nerve block is administered intraoperatively. As needed narcotic paper prescription is provided, same as in the experimental group. |
|
|
Experimental PEC II block group |
Patients receive wetting solution with only epinephrine in both breasts at the beginning of the case for hemostasis. The patient will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. As needed narcotic paper prescription is provided, same as in the control group. |
|
Recruiting Locations
Roanoke, Virginia 24014
More Details
- Status
- Recruiting
- Sponsor
- Carilion Clinic
Detailed Description
Participants will be initially identified and introduced to the study during preoperative breast reduction consultation in the office. Participants will be contacted via phone for the consenting process, and consented electronically, after their consultation. After completion of the consenting and enrollment process, participants will be entered into a software program will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, participants are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Participants will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Participants in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness. Participants will be sent surveys at postoperative days 1, 3, and 7 assessing patient pain control as a primary outcome (PROMIS Pain Intensity Survey) and secondary outcomes: narcotic usage and satisfaction level. If participants do not answer initial survey query after 24 hours, a follow up email or phone call will be completed to obtain the information on the following day. Statistical analysis will be performed on the primary outcome assessing non-inferiority between the two groups at all time points once at least 80 patients have enrolled in the study. Description of PECs II Block: The participant will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. "The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve" (Battista et al). The standard of care injection, whether a nerve block or subcutaneous infiltration typically utilizes only a local anesthetic such as bupivacaine. Multimodal Pain Regimen: Patients are advised to take 1000 mg of acetaminophen every 6 hours and 600 mg of ibuprofen every 6 hours both scheduled and staggered 3 hours apart. If patient weight <100 kg, oxycodone 5 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill. If patient weight >100 kg, oxycodone 10 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill.