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

August 14, 2024 updated by: Melinda Seering

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52245
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery
Time Frame: 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.
upon arrival to the recovery room after leaving the operating room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score Assessment-Post-operative Day 1
Time Frame: 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.
Day 1 post surgery
Pain Score Assessment-Post-operative Day 3
Time Frame: 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.
Day 3 post surgery
Pain Score Assessment-Post-operative Day 7
Time Frame: 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.
Day 7 post surgery
Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck.
Time Frame: 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.
Approximately day 14 post surgery
Measure the Amount of Narcotics Use to Control Pain.
Time Frame: 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.
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 the Amount of Narcotics Use to Control Pain (In-patient)
Time Frame: 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.
In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours
Measure the Amount of Narcotics Use to Control Pain (Intra-op)
Time Frame: 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.
Intra-operative (narcotics given during the operating room time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melinda Seering

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201805930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe