Clinical trial NCT03653988: Comparison of Pre-op and Post-op Pectoralis Nerve Block
Official title: Analgesia Efficacy of Pre-operative and Post-operative PEC I/II Block for Bilateral Mastectomy With Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Postoperative Pain
Anesthesia
Nerve Block
Keywords: Nerve block
Pectoralis nerve blocks
PECS I
PECS II
Mastectomy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CONTROLLED DOUBLE BLIND STUDY
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery
timeFrame: upon arrival to the recovery room after leaving the operating room
Secondary outcomes:
measure: Pain Score Assessment-Post-operative Day 1
timeFrame: Day 1 post surgery
measure: Pain Score Assessment-Post-operative Day 3
timeFrame: Day 3 post surgery
measure: Pain Score Assessment-Post-operative Day 7
timeFrame: Day 7 post surgery
measure: Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck.
timeFrame: Approximately day 14 post surgery
measure: Measure the Amount of Narcotics Use to Control Pain.
timeFrame: 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
measure: Measure the Amount of Narcotics Use to Control Pain (In-patient)
timeFrame: In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours
measure: Measure the Amount of Narcotics Use to Control Pain (Intra-op)
timeFrame: Intra-operative (narcotics given during the operating room time)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: Univerisity of Iowa Hospital & Clinics
name: Melinda Seering, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisity of Iowa Hospital & Clinics
name: Ingrid Lizarraga, MD
role: PRINCIPAL_INVESTIGATOR
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