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Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery

Primary Purpose

Quadratus Lumborum Block, Analgesia, Laparoscopic

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Retrolaminar block on the operative side
Quadratus lumborum block on the operative side
Transversus abdominis plane block on the nonoperative side
Sponsored by
dong zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quadratus Lumborum Block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-II class
  • Colorectal cancer patients
  • 18 and 80 years old
  • Elective laparoscopic colorectal surgery

Exclusion Criteria:

  • serious complications associated with other systems:
  • severe cardiac insufficiency
  • renal failure
  • hepatic encephalopathy
  • infection in the block injection area
  • coagulopathy
  • a known allergy to local anesthetics
  • a previous history of tranquilizer or opioid abuse,
  • body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2,
  • inability to cooperate with the assessment of visual analogue scale (VAS) pain scores
  • refusal to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    TR group

    TQ group

    Arm Description

    ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and retrolaminar block with 30-40 ml mixture 0.20% ropivacaine + dexamethasone 5 mg

    ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and quadratus lumborum block with 30 ml mixture 0.20% ropivacaine + dexamethasone 5 mg

    Outcomes

    Primary Outcome Measures

    the cumulative consumption of sufentanil
    the outcome in micrograms

    Secondary Outcome Measures

    the patient's mean arterial pressure (MAP), HR at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
    MAP in mmHg, HR in rate/one minute.
    cumulative sufentanil consumption at predetermined time intervals
    the outcome in minutes
    time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil
    the outcome in minutes
    the number of PCA press
    the outcome in frequency
    time until the earliest rescue analgesia and antiemetic
    the outcome in minutes
    the total dose of rescue analgesia and antiemetic
    the outcome in milligrams
    block-related complications
    such as hematoma, infection, quadriceps weakness, pneumothorax, deep visceral injury, and evidence of systemic toxicity to the local anesthetic
    other side events
    such as bradycardia (HR less than 60 beats per min), hypotension (systolic blood pressure less than 90 mmHg or more than 20% lower than baseline), hypoxemia (SpO2 less than 90%), respiratory depression (RR less than 10 breaths per min lasting for more than 10 min), pruritus, backache, nausea and vomiting
    patient satisfaction with pain management
    Patient satisfaction on postoperative analgesia using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied)
    the length of hospital stay
    the outcome in days
    Visual Analog Score (VAS) for pain at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
    The VAS is an internationally recognized scale for assessment of pain on an 11-point scale ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable (units on a scale)

    Full Information

    First Posted
    May 26, 2022
    Last Updated
    June 8, 2022
    Sponsor
    dong zhang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05416866
    Brief Title
    Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery
    Official Title
    Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery: A Randomized, Double-blind, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2022 (Anticipated)
    Primary Completion Date
    November 20, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    dong zhang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Our hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quadratus Lumborum Block, Analgesia, Laparoscopic, Colorectal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized, double-blind, controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Except the regional anesthesiologist who performed the blocks, patients, surgeons, theatre anesthesiologists, ward staff, caregivers, and the outcome assessor were unaware of group allocation. The regional anesthesiologist was not involved in the other parts of the study. All data was collected by personnel blinded to the patient group allocation.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TR group
    Arm Type
    Experimental
    Arm Description
    ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and retrolaminar block with 30-40 ml mixture 0.20% ropivacaine + dexamethasone 5 mg
    Arm Title
    TQ group
    Arm Type
    Experimental
    Arm Description
    ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and quadratus lumborum block with 30 ml mixture 0.20% ropivacaine + dexamethasone 5 mg
    Intervention Type
    Procedure
    Intervention Name(s)
    Retrolaminar block on the operative side
    Intervention Description
    After the skin near the puncture site was disinfected, 2ml of 1% lidocaine was injected into the puncture site for local infiltration. The needle was inserted beneath the ultrasound probe using an in-plane orientation to contact the lamina of the T8-T11 vertebra. Then we retracted the tip of needle to the lamina about 1 mm and withdrew to make sure that there was no blood or cerebrospinal fluid. Then, 30-40 mL mixture was injected posterior to the lamina of T8-T11.
    Intervention Type
    Procedure
    Intervention Name(s)
    Quadratus lumborum block on the operative side
    Intervention Description
    In our study, we applied a transmuscular approach to the QLB. After the patients were placed in the lateral position, the skin near the puncture site was disinfected, a low-frequency (3-5 MHz), curvilinear probe is used and is located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. After the local infiltration for puncture site, the 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the QL muscle is confirmed, 30 ml mixture is injected into the interfascial plane.
    Intervention Type
    Procedure
    Intervention Name(s)
    Transversus abdominis plane block on the nonoperative side
    Intervention Description
    After placing the patients in the supine position, the skin was disinfected. A linear probe was placed in the transverse plane at the midaxillary line between the lower costal margin and iliac crest. When the external oblique, internal oblique, and transversus abdominis muscles were observed, 2ml of 1% lidocaine was injected into the puncture site for local infiltration.Then, a 22-gauge, 80-mm needle was advanced using an in-plane technique in an anteromedial to posterolateral direction toward the TAP (the fascial plane between the internal oblique and transversus abdominis muscles). After the correct position of the needle tip was verified, 20 ml mixture was injected into the TAP. The ultrasound showed that the local anesthetic separated the internal oblique and transversus abdominis muscles, confirming the success of the block.
    Primary Outcome Measure Information:
    Title
    the cumulative consumption of sufentanil
    Description
    the outcome in micrograms
    Time Frame
    24 hours after nerves block
    Secondary Outcome Measure Information:
    Title
    the patient's mean arterial pressure (MAP), HR at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
    Description
    MAP in mmHg, HR in rate/one minute.
    Time Frame
    the time for completion of nerves block was time 0
    Title
    cumulative sufentanil consumption at predetermined time intervals
    Description
    the outcome in minutes
    Time Frame
    within 24 hour after nerves block
    Title
    time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil
    Description
    the outcome in minutes
    Time Frame
    within 24 hour after nerves block
    Title
    the number of PCA press
    Description
    the outcome in frequency
    Time Frame
    within 24 hour after nerves block
    Title
    time until the earliest rescue analgesia and antiemetic
    Description
    the outcome in minutes
    Time Frame
    within 24 hour after nerves block
    Title
    the total dose of rescue analgesia and antiemetic
    Description
    the outcome in milligrams
    Time Frame
    within 24 hour after nerves block
    Title
    block-related complications
    Description
    such as hematoma, infection, quadriceps weakness, pneumothorax, deep visceral injury, and evidence of systemic toxicity to the local anesthetic
    Time Frame
    within 24 hour after nerves block
    Title
    other side events
    Description
    such as bradycardia (HR less than 60 beats per min), hypotension (systolic blood pressure less than 90 mmHg or more than 20% lower than baseline), hypoxemia (SpO2 less than 90%), respiratory depression (RR less than 10 breaths per min lasting for more than 10 min), pruritus, backache, nausea and vomiting
    Time Frame
    within 24 hour after nerves block
    Title
    patient satisfaction with pain management
    Description
    Patient satisfaction on postoperative analgesia using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied)
    Time Frame
    at 24th hour after nerves block
    Title
    the length of hospital stay
    Description
    the outcome in days
    Time Frame
    up to 2 weeks
    Title
    Visual Analog Score (VAS) for pain at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
    Description
    The VAS is an internationally recognized scale for assessment of pain on an 11-point scale ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable (units on a scale)
    Time Frame
    the time for completion of nerves block was time 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-II class Colorectal cancer patients 18 and 80 years old Elective laparoscopic colorectal surgery Exclusion Criteria: serious complications associated with other systems: severe cardiac insufficiency renal failure hepatic encephalopathy infection in the block injection area coagulopathy a known allergy to local anesthetics a previous history of tranquilizer or opioid abuse, body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2, inability to cooperate with the assessment of visual analogue scale (VAS) pain scores refusal to participate in the study

    12. IPD Sharing Statement

    Learn more about this trial

    Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery

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