search
Back to results

PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction
Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Breast Reconstruction using the Latissimus Dorsi Flap

Exclusion Criteria:

  • All patients undergoing breast reconstruction using techniques other than the pedicled latissimus dorsi myocutaneous flap
  • Preexisting diagnosis of a chronic pain disorder
  • BMI > or = to 35/kg/m2
  • History of allergy or sensitivity to local anesthetic
  • History of coagulopathy or bleeding disorder
  • Weight <50Kg
  • Allergies to local anesthetic, celecoxib, acetaminophen, hydromorphone

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PEC1/SPB Block

    Intercostal Block

    Arm Description

    Outcomes

    Primary Outcome Measures

    Total 24 Hour Narcotic Usage
    This is the most common primary outcome used in the regional anesthesia literature when comparing nerve blocks.

    Secondary Outcome Measures

    Time to first analgesic request (TFA)
    Postoperative Pain score at 0h, 1h, 3h, 5h, 24 hours
    Patient self reported pain score at 24 hours post-surgery
    Peak expiratory flow rate
    Breast Q Questionnaire
    Physical and Psychological well-being questionnaire after breast reconstruction
    QoR-40 Patient Satisfaction Questionnaire
    Perioperative Care Satisfaction Questionnaire

    Full Information

    First Posted
    May 31, 2016
    Last Updated
    June 29, 2016
    Sponsor
    Ottawa Hospital Research Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02821676
    Brief Title
    PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
    Official Title
    A Randomized Controlled Comparison of PECI/SPB Versus Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Regional Anesthesia is a procedure in which numbing medication is injected around nerves that transmit pain from areas involved in a surgery. The objective is to block the nerves so a patient does not feel pain after surgery. Regional nerve blocks offer many advantages over traditional anesthetic techniques, including faster recovery time, fewer side effects and a dramatic reduction in post-surgical pain. The use of regional anesthesia in breast reconstructive surgery, such as the latissimus dorsi flap, has led to major improvements in patient care. Today, the most common regional anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block, where numbing medication is injected around the nerves supplying the chest wall. While intercostal nerve blocks have been used successfully in breast surgery, they do not provide a complete nerve block to the chest wall, as there are some nerves that are unaccounted for in the block which can contribute to a patients pain after surgery. The mixed pectoral one / serratus plane block (PECI/SPB) block is another regional nerve block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers a more complete pain blockade than the intercostal nerve block, as it includes more nerves that supply the breast. In addition to this, the intercostal nerve block is a so-called "blind-technique" compared to the PECI/SPB block, which is more accurately guided by ultrasound. Blind techniques are associated with higher failure rates. Both the intercostal nerve block and the PECI/SPB nerve block have been used successfully at the Ottawa Hospital. In this study, the investigators propose a prospective, double blinded, randomized controlled, head to head comparison of the PECI/SPB and intercostal nerve block to determine which block is associated with the best pain blockade and patient satisfaction in lattissimus dorsi flap surgery.
    Detailed Description
    Recent literature has unequivocally demonstrated that postoperative pain remains under-treated in hospitals. While breast surgery remains one of the most common surgeries performed in hospitals today, it has been shown that 40% of women still experience meaningful pain postoperatively. It is well known that poor pain control is not only associated with slower recovery, longer admission in hospital and poor patient satisfaction but it also can lead to the development of chronic post surgical pain. In recent years, regional nerve blocks have emerged as a promising adjunct to standard postoperative analgesic ladder protocols. The main advantage of regional anesthesia is the reduction of postoperative pain while limiting the amount of oral and intravenous narcotic use. The reduction of postoperative narcotic use is advantageous for the patient and caregiver alike as it reduces common side effects associated with such medications, such as drowsiness, nausea, vomiting, upset stomach and dizziness. Regional anesthesia in breast reconstruction surgery commonly include thoracic epidurals, intercostal nerve blocks and paravertebal nerve blocks. To date, there remains no standard of care for perioperative pain management and it is usually left to the discretion of the surgeon and anesthesiologist involved to decide which pain blockade is preferable on a case by case basis. While paravertebral and intercostal nerve blocks have shown promising results, they do not provide a complete sensory block to the anterior chest wall, as innervation is supplied not only from the thoracic spinal nerves but also via medial and lateral pectoral nerves off the brachial plexus. The pectoral nerve block is a novel interfascial block placed into the plane between pectoralis major and minor muscles and is particularly useful in reconstructive breast surgery involving subpectoral prosthesis. It has been associated with minimal analgesia postoperatively and is thought to be particularly useful in the daycare setting. To the best of the knowledge of the investigators, the utility of the pectoral nerve block in pedicled Latissimus Dorsi breast reconstruction has not been investigated. A mixed PEC I/ Serratus Plane Block provides analgesia to the lateral and medial pectoral nerves, lateral and anterior branches of the T2-T4 spinal nerves, long thoracic nerve and thoracodorsal nerve, theoretically offering a more comprehensive block than the midaxillary intercostal block and with no additional morbidity to the patient. Furthermore, the intercostal nerve block is a blind technique that may be associated with higher failure rates compared to the more precise, ultrasound guided, PECI/SPB block. In this study, the investigators plan to systematically investigate these two blocks in latissimus dorsi flap reconstruction in order to document optimal postoperative pain management.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PEC1/SPB Block
    Arm Type
    Experimental
    Arm Title
    Intercostal Block
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction
    Intervention Description
    30mL of 0.5% Ropivacaine with 1:200,000 epinephrine preoperatively via an ultrasound guided PECI/SPB regional block and 5mL of Normal Saline intraoperatively as an intercostal nerve block to each of the T2-T7 nerve segments
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction
    Intervention Description
    30mL of Normal Saline via an ultrasound guided PECI/SPB block and 5mL of 0.5% Ropivacaine with 1:200,000 epinephrine as an Intercostal nerve block to each of the T2-T7 nerve segments
    Primary Outcome Measure Information:
    Title
    Total 24 Hour Narcotic Usage
    Description
    This is the most common primary outcome used in the regional anesthesia literature when comparing nerve blocks.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Time to first analgesic request (TFA)
    Time Frame
    24 hours
    Title
    Postoperative Pain score at 0h, 1h, 3h, 5h, 24 hours
    Time Frame
    24 hours
    Title
    Patient self reported pain score at 24 hours post-surgery
    Time Frame
    24 hours
    Title
    Peak expiratory flow rate
    Time Frame
    24 hours
    Title
    Breast Q Questionnaire
    Description
    Physical and Psychological well-being questionnaire after breast reconstruction
    Time Frame
    24 hours
    Title
    QoR-40 Patient Satisfaction Questionnaire
    Description
    Perioperative Care Satisfaction Questionnaire
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Breast Reconstruction using the Latissimus Dorsi Flap Exclusion Criteria: All patients undergoing breast reconstruction using techniques other than the pedicled latissimus dorsi myocutaneous flap Preexisting diagnosis of a chronic pain disorder BMI > or = to 35/kg/m2 History of allergy or sensitivity to local anesthetic History of coagulopathy or bleeding disorder Weight <50Kg Allergies to local anesthetic, celecoxib, acetaminophen, hydromorphone
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael J Stein, MD
    Phone
    6132864646
    Email
    micstein@toh.on.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data will not be made available. Anonymity will be maintained throughout the study.

    Learn more about this trial

    PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction

    We'll reach out to this number within 24 hrs