Comparison of Pre-op and Post-op Pectoralis Nerve Block

Study Overview
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Brief Summary
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The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.

Detailed Description
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The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction cases. The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after the mastectomy. Patients undergoing mastectomies at the University of Iowa Hospitals clinics receive general anesthesia and a regional block for pain control. The most commonly employed regional anesthetic technique is a PECS I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PECS I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PECS II). The investigators will randomize patients into two groups and blind the patient and the research assistant collecting the data. Group I will have the block performed after induction of general anesthesia and prior to surgical incision by the anesthesiologist. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction. On the day of surgery, the investigators will have patients fill out forms to measure pain catastrophizing and depression and anxiety. The investigators would like to measure if there is any difference in postoperative pain scores (visual analogue scale)-immediately post surgery in post-anesthesia care unit (PACU), and then on the admission unit every 4 hours for the first twenty four hours or on discharge (whichever time-point occurs sooner) and will collect the average pain scale of the day on post-op day (POD) 2,3,5 and 7 via patient communication electronic message in RedCap. The investigators will also measure intraoperative and post-operative narcotic use (converted to morphine equivalents), post-operative nausea and vomiting, length of (PACU) stay. In addition the investigators will also collect pain scores and pain catastrophic scale on POD 14 after surgery at their clinic visits to the surgeon. Other data collected will include time taken to perform block, post-operative infection rate and post-operative flap necrosis rate.

Official Title
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Analgesia Efficacy of Pre-operative and Post-operative PEC I/II Block for Bilateral Mastectomy With Reconstruction

Conditions
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Nerve Block, Breast Cancer, Postoperative Pain, Anesthesia

Intervention / Treatment
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* Procedure: PEC I/II blocks by anesthesiologist - pre-operative
* Procedure: PEC I/II blocks by surgeon - intra-operative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Female Bilateral mastectomy for breast cancer Undergoing breast reconstruction Must weigh at least 50 kg Exclusion Criteria: More than 80 years of age Male Prisoners Patients who can't provide their own consent Lumpectomy only patients Patients having prophylactic mastectomies Patient must weigh at least 50 kg Allergies to local anesthetics Patient refusal Patients with a history of bleeding disorders Non-English speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMIZED CONTROLLED DOUBLE BLIND STUDY
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEC I/II block - pre-operative<br>The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction case. The intervention administered to Group I will having the block performed by the anesthesiologist after induction of general anesthesia and prior to surgical incision. | Procedure: PEC I/II blocks by anesthesiologist - pre-operative<br>* PEC I/II blocks by anesthesiologist - pre-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II). Group I will have the PEC block administered by the anesthesiologist prior to surgical incision.<br>|
| Experimental: PEC I/II block - intra-operative<br>The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction cases. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction. | Procedure: PEC I/II blocks by surgeon - intra-operative<br>* PEC I/II blocks by surgeon - intra-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessment using a visual analog scale-Immediately post-surgery | The primary outcome to be assessed is to determine if there is a quantitative difference in post-operative pain scores as a result of the administration of a pre-operative PECS I/II block versus the administration of an intra-operative PECS I/II block (Post mastectomy but prior to breast reconstruction). The visual analog scale is a unidimensional measure of pain used in a diverse adult population. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. | The initial assessment will occur immediately post-surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessment-Post-operative day 2 | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. | Day 2 post surgery | 
| Pain score assessment-Post-operative day 3 | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. | Day 3 post surgery | 
| Pain score assessment-Post-operative day 5 | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. | Day 5 post surgery | 
| Pain score assessment-Post-operative day 7 | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. | Day 7 post surgery | 
| Pain score assessment using a visual analog scale-Post-operative surgical recheck. | When the patient returns to visit with their surgeon approximately 14 days after their surgical procedure, using the visual analog scale the subjects will report their average pain score. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. | Approximately day 14 post surgery | 
| Measure the amount of narcotics use to control pain. | The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects. | For up to two weeks following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nerve block, Pectoralis nerve blocks, PECS I, PECS II, Mastectomy