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Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT02007096
Collaborator
(none)
127
Enrollment
1
Location
2
Arms
26
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

Condition or Disease Intervention/Treatment Phase
  • Drug: Transabdominal Plane Block
  • Drug: Non Transabdominal Plane Block
 Phase 2

Detailed Description

Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.

Study Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Transabdominal Plane (TAP) Blocks in Ventral Hernia Repair
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transabdominal Plane Block

Receiving Transabdominal Plane Block with 0.25% bupivacaine

Drug: Transabdominal Plane Block
0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total
Other Names:
  • Bupivacaine

    		•
    Placebo Comparator: Non Transabdominal Plane Block

    Receiving placebo saline injection

    Drug: Non Transabdominal Plane Block
    Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-operative Opioid Use [up to 24 hours]

      Amount of opioids used by patients at certain time points.

    Secondary Outcome Measures

    1. Pain Score [1 hour postoperatively]

      Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."

    2. Operating Procedure Time [Procedure begin time to procedure end time]

      Total number of minutes for the procedure, not including anesthesia time.

    3. Pain Score [24 hours postoperatively]

      Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age 18 and older

    • elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital

    Exclusion Criteria:

    • age younger than 18

    • allergic reaction to bupivacaine

    • allergic reaction to opioids

    • opioid substance abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Icahn School of Medicine at Mount Sinai New York New York United States 10029

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Principal Investigator: Celia M Divino, MD, FACS, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celia M. Divino, Professor, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT02007096
    Other Study ID Numbers:
    • GCO 12-0960
    First Posted:
    Dec 10, 2013
    Last Update Posted:
    Jan 19, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Celia M. Divino, Professor, Icahn School of Medicine at Mount Sinai
    Transabdominal plane block
    ventral hernia
    umbilical hernia
    incisional hernia
    hernia repair
    Additional relevant MeSH terms:
    Hernia, Umbilical
    Hernia
    Pain, Postoperative
    Postoperative Complications
    Hernia, Ventral
    Incisional Hernia
    Bupivacaine

    Study Results

    Participant Flow

    Recruitment Details Participants recruited from the Department of Surgery at The Mount Sinai Hospital between November 2012 and October 2014.
    Pre-assignment Detail
    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection
    Period Title: Overall Study
    STARTED 63 64
    COMPLETED 52 48
    NOT COMPLETED 11 16

    Baseline Characteristics

    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block Total
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection Total of all reporting groups
    Overall Participants 52 48 100
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.67
    (12.89)
    53.81
    (13.45)
    53.22
    (13.11)
    Sex: Female, Male (Count of Participants)
    Female
    27
    51.9%
    21
    43.8%
    48
    48%
    Male
    25
    48.1%
    27
    56.3%
    52
    52%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    30.91
    (5.45)
    31.16
    (7.00)
    31.03
    (6.21)
    ASA class (Count of Participants)
    1
    7
    13.5%
    6
    12.5%
    13
    13%
    2
    24
    46.2%
    24
    50%
    48
    48%
    3
    20
    38.5%
    16
    33.3%
    36
    36%
    4
    1
    1.9%
    2
    4.2%
    3
    3%
    Hypertension (Count of Participants)
    Count of Participants [Participants]
    25
    48.1%
    23
    47.9%
    48
    48%
    Diabetes (Count of Participants)
    Count of Participants [Participants]
    10
    19.2%
    9
    18.8%
    19
    19%
    Hyperlipidemia (Count of Participants)
    Count of Participants [Participants]
    14
    26.9%
    20
    41.7%
    34
    34%
    Coronary artery disease (Count of Participants)
    Count of Participants [Participants]
    6
    11.5%
    9
    18.8%
    15
    15%
    GERD (Count of Participants)
    Count of Participants [Participants]
    12
    23.1%
    13
    27.1%
    25
    25%
    Smoker (Count of Participants)
    Count of Participants [Participants]
    15
    28.8%
    17
    35.4%
    32
    32%
    Previous abdominal surgery (Count of Participants)
    Count of Participants [Participants]
    41
    78.8%
    31
    64.6%
    72
    72%
    Hernia defect size (cm^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm^2]
    38.46
    (42.26)
    39.84
    (61.27)
    39.12
    (51.99)
    Location of hernia defect (Count of Participants)
    Epigastric
    23
    44.2%
    18
    37.5%
    41
    41%
    Umbilical
    19
    36.5%
    20
    41.7%
    39
    39%
    Infraumbilical
    2
    3.8%
    7
    14.6%
    9
    9%
    Lateral
    8
    15.4%
    3
    6.3%
    11
    11%
    LOS (Count of Participants)
    <2 days
    35
    67.3%
    36
    75%
    71
    71%
    ≥2 days
    17
    32.7%
    12
    25%
    29
    29%

    Outcome Measures

    1. Primary Outcome
    Title Post-operative Opioid Use
    Description Amount of opioids used by patients at certain time points.
    Time Frame up to 24 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection
    Measure Participants 52 48
    at 6 hours
    10.59
    (0)
    15.62
    (0)
    at 12 hours
    16.09
    (0)
    32.24
    (0)
    at 18 hours
    20.70
    (0)
    39.37
    (0)
    at 24 hours
    25.64
    (0)
    42.56
    (0)
    2. Secondary Outcome
    Title Pain Score
    Description Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."
    Time Frame 1 hour postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection
    Measure Participants 52 48
    pain scores at rest
    5.19
    (0.39)
    6.46
    (0.38)
    pain scores with movement
    6.15
    (0.42)
    7.73
    (0.40)
    3. Secondary Outcome
    Title Operating Procedure Time
    Description Total number of minutes for the procedure, not including anesthesia time.
    Time Frame Procedure begin time to procedure end time

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection
    Measure Participants 52 48
    Mean (Standard Deviation) [min]
    97.41
    (30.22)
    98.81
    (37.51)
    4. Secondary Outcome
    Title Pain Score
    Description Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."
    Time Frame 24 hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection
    Measure Participants 52 48
    pain scores at rest
    4.60
    (0.39)
    4.52
    (0.31)
    pain scores with movement
    6.75
    (0.38)
    6.98
    (0.40)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Adverse Events information not collected
    Arm/Group Title Transabdominal Plane Block Non Transabdominal Plane Block
    Arm/Group Description Transabdominal Plane Block with 0.25% bupivacaine Non Transabdominal Plane Block: Saline injection
    All Cause Mortality
    Transabdominal Plane Block Non Transabdominal Plane Block
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Transabdominal Plane Block Non Transabdominal Plane Block
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Transabdominal Plane Block Non Transabdominal Plane Block
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    The surgeon knew the group assignment to administer the correct injection. Data not collected on clinical difference, e.g. postop nausea & vomiting. Study conducted at one center with experienced surgeons, so the results might not be generalizable.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Celia M Divino
    Organization Division of General Surgery, Department of Surgery, The Mount Sinai Medical Center
    Phone 212-241-5499
    Email Celia.Divino@mountsinai.org
    Responsible Party:
    Celia M. Divino, Professor, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT02007096
    Other Study ID Numbers:
    • GCO 12-0960
    First Posted:
    Dec 10, 2013
    Last Update Posted:
    Jan 19, 2018
    Last Verified:
    Jan 1, 2018