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Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement

Primary Purpose

Postoperative Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic guided nerve blocks
Ropivacaine
Sponsored by
Marcus Malek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postoperative Pain focused on measuring nerve block, laparoscopy, anesthesia

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients 5 - 17 years old.
  2. Patients undergoing laparoscopic procedures
  3. Patients that weigh greater than or equal to 34 kg and less than 100 kg.

Exclusion Criteria:

  1. Patients who underwent open surgical procedures will be excluded from this study.
  2. Patients that weigh less than 34kg.
  3. Patients that weigh more than 100 kg.
  4. Perforated appendicitis.
  5. Bowel obstruction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Arm Label

    Local port site injection

    Ultrasound-guided nerve blocks

    Laparoscopic guided nerve blocks

    Arm Description

    These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.

    Outcomes

    Primary Outcome Measures

    Minutes under anesthesia

    Secondary Outcome Measures

    Pain scores
    Narcotic usage

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    March 4, 2020
    Sponsor
    Marcus Malek
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02945696
    Brief Title
    Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
    Official Title
    Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding issues
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2020 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Marcus Malek

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
    Detailed Description
    Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11. The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks. The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    nerve block, laparoscopy, anesthesia

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Local port site injection
    Arm Type
    No Intervention
    Arm Title
    Ultrasound-guided nerve blocks
    Arm Type
    No Intervention
    Arm Title
    Laparoscopic guided nerve blocks
    Arm Type
    Experimental
    Arm Description
    These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic guided nerve blocks
    Intervention Description
    It is common to use ultrasound to define the correct plane for abdominal wall nerve blocks, however, the utilization of laparoscopy to identify this plane is a new intervention that is previously undescribed in children.
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Description
    Ropivacaine is a local anesthetic used to prevent pain during and after procedures. In this study, ropivacaine will be injected either directly at the port sites, or for a regional abdominal wall nerve block, either under ultrasound or laparoscopic guidance.
    Primary Outcome Measure Information:
    Title
    Minutes under anesthesia
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Pain scores
    Time Frame
    2 years
    Title
    Narcotic usage
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 5 - 17 years old. Patients undergoing laparoscopic procedures Patients that weigh greater than or equal to 34 kg and less than 100 kg. Exclusion Criteria: Patients who underwent open surgical procedures will be excluded from this study. Patients that weigh less than 34kg. Patients that weigh more than 100 kg. Perforated appendicitis. Bowel obstruction

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement

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