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

Primary Purpose

Breast Cancer, Postoperative Pain, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEC I/II blocks by anesthesiologist - pre-operative
PEC I/II blocks by surgeon - intra-operative
Sponsored by
Melinda Seering
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Nerve block, Pectoralis nerve blocks, PECS I, PECS II, Mastectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PEC I/II block - pre-operative

PEC I/II block - intra-operative

Arm 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 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 14, 2018
Last Updated
November 30, 2021
Sponsor
Melinda Seering
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1. Study Identification

Unique Protocol Identification Number
NCT03653988
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Melinda Seering

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Postoperative Pain, Anesthesia, Nerve Block
Keywords
Nerve block, Pectoralis nerve blocks, PECS I, PECS II, Mastectomy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CONTROLLED DOUBLE BLIND STUDY
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEC I/II block - pre-operative
Arm Type
Active Comparator
Arm 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 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.
Arm Title
PEC I/II block - intra-operative
Arm Type
Experimental
Arm 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. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction.
Intervention Type
Procedure
Intervention Name(s)
PEC I/II blocks by anesthesiologist - pre-operative
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PEC I/II blocks by surgeon - intra-operative
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain score assessment using a visual analog scale-Immediately post-surgery
Description
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.
Time Frame
The initial assessment will occur immediately post-surgery.
Secondary Outcome Measure Information:
Title
Pain score assessment-Post-operative day 2
Description
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.
Time Frame
Day 2 post surgery
Title
Pain score assessment-Post-operative day 3
Description
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.
Time Frame
Day 3 post surgery
Title
Pain score assessment-Post-operative day 5
Description
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.
Time Frame
Day 5 post surgery
Title
Pain score assessment-Post-operative day 7
Description
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.
Time Frame
Day 7 post surgery
Title
Pain score assessment using a visual analog scale-Post-operative surgical recheck.
Description
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.
Time Frame
Approximately day 14 post surgery
Title
Measure the amount of narcotics use to control pain.
Description
The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.
Time Frame
For up to two weeks following surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients with breast cancer scheduled to undergo mastectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Seering, MD
Organizational Affiliation
Univerisity of Iowa Hospital & Clinics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ingrid Lizarraga, MD
Organizational Affiliation
Univerisity of Iowa Hospital & Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD Sharing Time Frame
IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD Sharing Access Criteria
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
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Comparison of Pre-op and Post-op Pectoralis Nerve Block

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