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Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Normal saline
Ropivacaine
Compound lidocaine
Esketamine
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Compound lidocaine, Esketamine, Quadratus lumborum block, opioid consumption

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is scheduled to undergo colorectal cancer surgery under general anesthesia Subject's American Society of Anesthesiologists physical status is I-III. The subject's parent/legally authorized guardian has given written informed consent to participate Exclusion Criteria: Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. Subject has a diagnosis of Insulin dependent diabetes. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. Subject has any contraindication for the use of patient-controlled analgesia (PCA). Subject is pregnant or breast-feeding. Subject is obese (body mass index >30kg/m^2). Subject is incapacity to comprehend pain assessment and cognitive assessment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Normal saline in quadratus lumborum block

    Ropivacaine in quadratus lumborum block

    Compound lidocaine in quadratus lumborum block

    Compound lidocaine and esketamine in quadratus lumborum block

    Arm Description

    After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

    After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

    After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

    After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side.

    Outcomes

    Primary Outcome Measures

    Postoperative opioid consumption
    Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 72 hours postoperatively.

    Secondary Outcome Measures

    Pain Score (NRS)
    The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain.
    Time of First Postoperative Analgesic Requirement
    First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
    Total Dose of First Postoperative Analgesic Requirement
    First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
    The incidence of Side Effects
    The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 72 hours postoperatively.
    Apfel score
    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
    Mean time until passage of flatus
    Gastrointestinal motility was evaluated by recording mean time until passage of flatus
    Diffusion area of local anesthetics after quadratus lumborum block
    Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance.
    Normalized Area of Hyperalgesia Around the Incision
    The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
    The level of cytokines in blood By ELISA kits
    Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.
    The level of chemokines in blood By ELISA kits
    Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.

    Full Information

    First Posted
    July 20, 2023
    Last Updated
    July 20, 2023
    Sponsor
    Tianjin Medical University General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05964985
    Brief Title
    Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery
    Official Title
    Effect of Ultrasound-guided Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Surgery: a Randomized Double-blind Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 6, 2023 (Anticipated)
    Primary Completion Date
    January 15, 2024 (Anticipated)
    Study Completion Date
    February 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tianjin Medical University General Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Purpose: To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal surgery.
    Detailed Description
    Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation, and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal analgesia strategies to minimise opioidrelated side effects are highly desirable in open surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is most commonly used forthis technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the quadratus lumborum block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Compound lidocaine, Esketamine, Quadratus lumborum block, opioid consumption

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal saline in quadratus lumborum block
    Arm Type
    Placebo Comparator
    Arm Description
    After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
    Arm Title
    Ropivacaine in quadratus lumborum block
    Arm Type
    Active Comparator
    Arm Description
    After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
    Arm Title
    Compound lidocaine in quadratus lumborum block
    Arm Type
    Active Comparator
    Arm Description
    After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
    Arm Title
    Compound lidocaine and esketamine in quadratus lumborum block
    Arm Type
    Active Comparator
    Arm Description
    After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Other Intervention Name(s)
    0. 9% Sodium Chloride Injection
    Intervention Description
    After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Ropivacaine Hydrochloride Injection
    Intervention Description
    After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
    Intervention Type
    Drug
    Intervention Name(s)
    Compound lidocaine
    Other Intervention Name(s)
    Compound Lidocaine Hydrochloride Injection
    Intervention Description
    After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine
    Other Intervention Name(s)
    Esketamine injection
    Intervention Description
    After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block
    Primary Outcome Measure Information:
    Title
    Postoperative opioid consumption
    Description
    Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 72 hours postoperatively.
    Time Frame
    72 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Pain Score (NRS)
    Description
    The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain.
    Time Frame
    72 hours after surgery
    Title
    Time of First Postoperative Analgesic Requirement
    Description
    First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
    Time Frame
    1 hour after surgery
    Title
    Total Dose of First Postoperative Analgesic Requirement
    Description
    First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
    Time Frame
    1 hour after surgery
    Title
    The incidence of Side Effects
    Description
    The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 72 hours postoperatively.
    Time Frame
    72 hours after surgery
    Title
    Apfel score
    Description
    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
    Time Frame
    The 1 day before the surgery
    Title
    Mean time until passage of flatus
    Description
    Gastrointestinal motility was evaluated by recording mean time until passage of flatus
    Time Frame
    96 hours after surgery
    Title
    Diffusion area of local anesthetics after quadratus lumborum block
    Description
    Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance.
    Time Frame
    30 minutes after quadratus lumborum block
    Title
    Normalized Area of Hyperalgesia Around the Incision
    Description
    The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
    Time Frame
    72 hours after surgery
    Title
    The level of cytokines in blood By ELISA kits
    Description
    Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.
    Time Frame
    72 hours after surgery
    Title
    The level of chemokines in blood By ELISA kits
    Description
    Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.
    Time Frame
    72 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is scheduled to undergo colorectal cancer surgery under general anesthesia Subject's American Society of Anesthesiologists physical status is I-III. The subject's parent/legally authorized guardian has given written informed consent to participate Exclusion Criteria: Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. Subject has a diagnosis of Insulin dependent diabetes. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. Subject has any contraindication for the use of patient-controlled analgesia (PCA). Subject is pregnant or breast-feeding. Subject is obese (body mass index >30kg/m^2). Subject is incapacity to comprehend pain assessment and cognitive assessment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guolin Wang, MD
    Phone
    +86 15822855556
    Email
    wangguolinghad@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guolin Wang, MD
    Organizational Affiliation
    Tianjin Medical University General Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery

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