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

Sponsor

Melinda Seering (Other)

Overall Status

Completed

CT.gov ID

NCT03653988

Collaborator

(none)

Enrollment

Location

Arms

31.7

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Postoperative Pain Anesthesia Nerve Block	Procedure: PEC I/II blocks by anesthesiologist - pre-operative Procedure: PEC I/II blocks by surgeon - intra-operative	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RANDOMIZED CONTROLLED DOUBLE BLIND STUDYRANDOMIZED CONTROLLED DOUBLE BLIND STUDY

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Mar 12, 2019

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PEC I/II block - 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.	Procedure: PEC I/II blocks by anesthesiologist - pre-operative 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.
Experimental: PEC I/II block - 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.	Procedure: PEC I/II blocks by surgeon - intra-operative 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).

Arm

Intervention/Treatment

Active Comparator: PEC I/II block - 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.

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

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.

Experimental: PEC I/II block - 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.

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

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).

Outcome Measures

Primary Outcome Measures

Pain score assessment using a visual analog scale-Immediately post-surgery [The initial assessment will occur 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.

Secondary Outcome Measures

Pain score assessment-Post-operative day 2 [Day 2 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 5 [Day 5 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.
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.
Measure the amount of narcotics use to control pain. [For up to two weeks following surgery]
The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52245

Sponsors and Collaborators

Melinda Seering

Investigators

Principal Investigator: Melinda Seering, MD, Univerisity of Iowa Hospital & Clinics
Principal Investigator: Ingrid Lizarraga, MD, Univerisity of Iowa Hospital & Clinics