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Pectoralis and Serratus Nerves Block in Thoracic Surgery

Primary Purpose

Anesthesia, Surgery, Block

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Ultrasound
Thoracotomy
Opioids
NSAID
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  1. All patients undergoing thoracic surgery, older ≥18 years
  2. Patients who meet criteria of ASA I-II-III class.

Exclusion Criteria:

  1. Patients who will be unconscious or mentally incompetent
  2. Patients refusal to participate in the study
  3. ASA -IV -V
  4. Patient with coagulopathy
  5. Hemodynamically unstable (systolic BP < 90, HR > 100)
  6. Allergy to local anesthetic drugs or opioids
  7. Pregnant patient
  8. History of opioid abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pectoralic block group

    Control group

    Arm Description

    After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.

    Patients in this group will receive standard pain control with opioids and NSAIDs

    Outcomes

    Primary Outcome Measures

    Comparison Visual Analog Score between groups
    First VAS after admission in PACU

    Secondary Outcome Measures

    Total NSAIDs dosage (mg) in the PACU and department
    While the patient is in PACU
    Length of hospital stay
    Measuring time of at discharge from hospital
    Total morphine dosage (mg) in the PACU and department
    While the patient is in PACU

    Full Information

    First Posted
    January 3, 2017
    Last Updated
    January 17, 2017
    Sponsor
    Soroka University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03023982
    Brief Title
    Pectoralis and Serratus Nerves Block in Thoracic Surgery
    Official Title
    Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves block) has been described for pain control after thoracic surgery, one of the indications to perform this method is analgesia for surgeries or procedures involving lateral chest wall
    Detailed Description
    The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral prosthesis for pain control management. This block is provided by injection into another myofascial plane, this time between pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block is simple in performance with a high success rate and minimal incidence of complications, especially, if used ultrasound approach that gives a good understanding of anatomy of the lateral thoracic wall. In present clinical trial we are going to compare PECs block for pain control with traditional pain management techniques based on IV opioids and NSAIDs treatment in patient undergoing thoracic surgery in early postoperative period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Surgery, Block, Thoracic Injury

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pectoralic block group
    Arm Type
    Experimental
    Arm Description
    After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group will receive standard pain control with opioids and NSAIDs
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine Hydrochloride
    Other Intervention Name(s)
    Marcaine
    Intervention Description
    40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Other Intervention Name(s)
    Sonosite
    Intervention Description
    All blocks will be done under ultrasound
    Intervention Type
    Procedure
    Intervention Name(s)
    Thoracotomy
    Intervention Description
    The patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle.
    Intervention Type
    Drug
    Intervention Name(s)
    Opioids
    Other Intervention Name(s)
    Morphine
    Intervention Description
    standard pain control with opioids
    Intervention Type
    Drug
    Intervention Name(s)
    NSAID
    Other Intervention Name(s)
    Perfalgan
    Intervention Description
    standard pain control with NSAIDs
    Primary Outcome Measure Information:
    Title
    Comparison Visual Analog Score between groups
    Description
    First VAS after admission in PACU
    Time Frame
    First 24 hours from the surgery
    Secondary Outcome Measure Information:
    Title
    Total NSAIDs dosage (mg) in the PACU and department
    Description
    While the patient is in PACU
    Time Frame
    First 24 hours from the surgery
    Title
    Length of hospital stay
    Description
    Measuring time of at discharge from hospital
    Time Frame
    up to 21 days
    Title
    Total morphine dosage (mg) in the PACU and department
    Description
    While the patient is in PACU
    Time Frame
    First 24 hours from the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients undergoing thoracic surgery, older ≥18 years Patients who meet criteria of ASA I-II-III class. Exclusion Criteria: Patients who will be unconscious or mentally incompetent Patients refusal to participate in the study ASA -IV -V Patient with coagulopathy Hemodynamically unstable (systolic BP < 90, HR > 100) Allergy to local anesthetic drugs or opioids Pregnant patient History of opioid abuse

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    will be decided later

    Learn more about this trial

    Pectoralis and Serratus Nerves Block in Thoracic Surgery

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