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Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection

Primary Purpose

Lidocaine, Analgesia, Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
normal saline
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lidocaine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: participants ages 18-70 years. participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery. American Society of Anesthesiologists classification (ASA)I-III. Exclusion Criteria: severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III. hypersensitivity to lidocaine,History of local anesthetic poisoning. severe renal or hepatic dysfunction. body mass index (BMI)>35 kg m-2. severe pleural adhesions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    lidocaine

    normal saline

    Arm Description

    Patients in this group will receive continuous lidocaine infusion via closed chest drainage tube. The pulse infusion speed is 1ml / 30min, and the continuous infusion speed was 2ml / h.

    Patients in this group will receive continuous normal saline infusion via closed chest drainage tube. The pulse infusion speed is same as the lidocaine group.

    Outcomes

    Primary Outcome Measures

    postoperative pain score(NRS)
    The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment. In this study,the investigators mainly investigated the incidence of postoperative pain score was greater than 3 in each group.

    Secondary Outcome Measures

    Changes in postoperative pain
    Changes in postoperative pain score (NRS) at 12h and 48h until extubation. The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment.
    the use of flurbiprofen axetil
    the amount of rescue analgesic drugs flurbiprofen axetil used
    the use of dolantin
    the amount of rescue analgesic drugs dolantin used
    the use of opioids
    total amount of opioid use within 48h after surgery
    postoperative adverse events
    the incidence of nausea, vomiting, and vertigo after surgery
    the amount of postoperative wound drainage
    total amount of fluid drained after surgery
    C-reactive protein
    The inflammatory marker of participants will be test after surgery
    interleukin-6
    The inflammatory marker of participants will be test after surgery
    postoperative delusion
    The incidence of postoperative delusion.
    drainage extraction
    The time taken for the patient to remove the drain after surgery
    ICU stay time
    The length of time the patient remains in the ICU.
    postoperative pulmonary complications
    The probability of patients acquiring pulmonary complications after surgery.
    hospital length of stay
    The time between hospital admission and discharge
    healing rate of drainage wound
    The healing rate of drainage wound at 21 days after surgery.
    readmission rate
    The readmission rate of patients in one month after surgery.

    Full Information

    First Posted
    May 3, 2023
    Last Updated
    June 12, 2023
    Sponsor
    Qilu Hospital of Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05901389
    Brief Title
    Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection
    Official Title
    Effects of Continuous Lidocaine Infusion Via Closed Chest Drainage Tube on Postoperative Analgesia for Patients Undergoing Thoracoscopic Partial Lung Resection: a Single-center Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qilu Hospital of Shandong University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are: To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy. Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery. For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.
    Detailed Description
    At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia. The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored. In the protocol,participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lidocaine, Analgesia, Pain, Postoperative, Thoracic Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    lidocaine will be injection by electronic analgesic pump, and the pulse infusion speed is 1ml / 30min, and 2ml / h for continuous infusion
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    456 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    lidocaine
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive continuous lidocaine infusion via closed chest drainage tube. The pulse infusion speed is 1ml / 30min, and the continuous infusion speed was 2ml / h.
    Arm Title
    normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in this group will receive continuous normal saline infusion via closed chest drainage tube. The pulse infusion speed is same as the lidocaine group.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    After the thoracoscopic surgery, lidocaine will be transfused through the epidural tube fixed in the chest drainage tube was connected to an electronic pump whose parameters are already set up (marking the chest drain for analgesia).
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Intervention Description
    After the thoracoscopic surgery, normal saline will be transfused through the epidural tube fixed in the chest drainage tube was connected to an electronic pump whose parameters are already set up (marking the chest drain for analgesia).
    Primary Outcome Measure Information:
    Title
    postoperative pain score(NRS)
    Description
    The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment. In this study,the investigators mainly investigated the incidence of postoperative pain score was greater than 3 in each group.
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Changes in postoperative pain
    Description
    Changes in postoperative pain score (NRS) at 12h and 48h until extubation. The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment.
    Time Frame
    Day 2
    Title
    the use of flurbiprofen axetil
    Description
    the amount of rescue analgesic drugs flurbiprofen axetil used
    Time Frame
    Day 3
    Title
    the use of dolantin
    Description
    the amount of rescue analgesic drugs dolantin used
    Time Frame
    Day 3
    Title
    the use of opioids
    Description
    total amount of opioid use within 48h after surgery
    Time Frame
    Day 2
    Title
    postoperative adverse events
    Description
    the incidence of nausea, vomiting, and vertigo after surgery
    Time Frame
    Day 3
    Title
    the amount of postoperative wound drainage
    Description
    total amount of fluid drained after surgery
    Time Frame
    Day 3
    Title
    C-reactive protein
    Description
    The inflammatory marker of participants will be test after surgery
    Time Frame
    Day 1
    Title
    interleukin-6
    Description
    The inflammatory marker of participants will be test after surgery
    Time Frame
    Day 1
    Title
    postoperative delusion
    Description
    The incidence of postoperative delusion.
    Time Frame
    Day 3
    Title
    drainage extraction
    Description
    The time taken for the patient to remove the drain after surgery
    Time Frame
    up to 24 hours (before extubation)
    Title
    ICU stay time
    Description
    The length of time the patient remains in the ICU.
    Time Frame
    From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
    Title
    postoperative pulmonary complications
    Description
    The probability of patients acquiring pulmonary complications after surgery.
    Time Frame
    Day 3
    Title
    hospital length of stay
    Description
    The time between hospital admission and discharge
    Time Frame
    From date of hospital admission until the date of discharge,assessed up to 15 days.
    Title
    healing rate of drainage wound
    Description
    The healing rate of drainage wound at 21 days after surgery.
    Time Frame
    Day 21
    Title
    readmission rate
    Description
    The readmission rate of patients in one month after surgery.
    Time Frame
    Month 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: participants ages 18-70 years. participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery. American Society of Anesthesiologists classification (ASA)I-III. Exclusion Criteria: severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III. hypersensitivity to lidocaine,History of local anesthetic poisoning. severe renal or hepatic dysfunction. body mass index (BMI)>35 kg m-2. severe pleural adhesions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinying Zhang
    Phone
    18560087707
    Email
    zhjydzx@163.com

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    Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection

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