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

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ClinicalTrials.gov Identifier: NCT03653988
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Melinda Seering, University of Iowa

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMIZED 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 : March 12, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

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).




Primary Outcome Measures :
  1. Pain score assessment using a visual analog scale-Immediately post-surgery [ Time Frame: 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 :
  1. Pain score assessment-Post-operative day 2 [ Time Frame: 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.

  2. 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.

  3. Pain score assessment-Post-operative day 5 [ Time Frame: 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.

  4. 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.

  5. 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.

  6. Measure the amount of narcotics use to control pain. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients with breast cancer scheduled to undergo mastectomy
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653988


Contacts
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Contact: Melinda Seering, MD (319) 384-8466 melinda-seering@uiowa.edu
Contact: Ingrid Lizarraga, MD (319) 356-1727 ingrid-lizarraga@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52245
Contact: Melinda Seering, MD    319-384-8466    melinda-seering@uiowa.edu   
Sponsors and Collaborators
Melinda Seering
Investigators
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Principal Investigator: Melinda Seering, MD Univerisity of Iowa Hospital & Clinics
Principal Investigator: Ingrid Lizarraga, MD Univerisity of Iowa Hospital & Clinics

Publications:

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Responsible Party: Melinda Seering, Principle Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03653988     History of Changes
Other Study ID Numbers: 201805930
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melinda Seering, University of Iowa:
Nerve block
Pectoralis nerve blocks
PECS I
PECS II
Mastectomy

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms