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

Not Applicable

Completed

Conditions: Breast Cancer
Nerve Block
Postoperative Pain
Anesthesia

Interventions: Procedure: PEC I/II blocks by anesthesiologist - pre-operative
Procedure: PEC I/II blocks by surgeon - intra-operative

Registration Number: NCT03653988

Lead Sponsor: Melinda Seering

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEC I/II block - pre-operative	PEC I/II blocks by anesthesiologist - pre-operative	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.
PEC I/II block - intra-operative	PEC I/II blocks by surgeon - intra-operative	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.

Primary Outcome Measures

Name	Time	Method
Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery	upon arrival to the recovery room after leaving the operating room	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.

Secondary Outcome Measures

Name	Time	Method
Measure the Amount of Narcotics Use to Control Pain (Intra-op)	Intra-operative (narcotics given during the operating room time)	The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.
Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck.	Approximately day 14 post surgery	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.
Pain Score Assessment-Post-operative Day 1	Day 1 post surgery	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.
Pain Score Assessment-Post-operative Day 3	Day 3 post surgery	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.
Pain Score Assessment-Post-operative Day 7	Day 7 post surgery	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.
Measure the Amount of Narcotics Use to Control Pain.	PACU (from time patient left operating room until patient is discharged from the recovery area to in-patient unit). The time limit for this is generally 60-90 minutes	The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.
Measure the Amount of Narcotics Use to Control Pain (In-patient)	In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours	The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.