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The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries (TAP)

Primary Purpose

Abdominal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacaine (Transversus Abdominis Plane Block)
Intravenous Patient Controlled Analgesia (PCA) Morphine
Sponsored by
Rajiv Gandhi Cancer Institute & Research Center, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Cancer focused on measuring Transverse Abdominis Plane (TAP) Block, Patient Control Analgesia (PCA)

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration.

Exclusion Criteria:

  • Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Transversus Abdominis Plane (TAP) Block Group

    Control Group (No TAP Block)

    Arm Description

    Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours.

    The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.
    In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.

    Secondary Outcome Measures

    Total and Good demands for PCA IV Morphine in milligrams in both the groups.
    In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied.

    Full Information

    First Posted
    May 18, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Rajiv Gandhi Cancer Institute & Research Center, India
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03165383
    Brief Title
    The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries
    Acronym
    TAP
    Official Title
    The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Block in Lower Abdominal OncoSurgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 11, 2013 (Actual)
    Primary Completion Date
    July 10, 2014 (Actual)
    Study Completion Date
    August 20, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rajiv Gandhi Cancer Institute & Research Center, India

    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
    Effective postoperative pain control results in decreased cardiac and pulmonary complications, patient satisfaction and early mobilization. A prospective, randomized comparative study was done of analgesic efficacy, opioid requirement and side effects in patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given. Patient controlled analgesia (PCA) with intravenous morphine was given to both group patients, and total good PCA demands in both the groups was studied.
    Detailed Description
    Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled in the study. After obtaining written informed consent from all the patients, they were randomly allotted to either Study (TAP) Group or Control group. Standard general anesthesia with endotracheal intubation was performed in all the patients. Preoperatively all patients received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump. After the end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was placed about 6-8 cms in situ. Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8 hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours. The PCA Pump was set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10 minutes. In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours. Total and good PCA demands upto 24 hours was recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Cancer
    Keywords
    Transverse Abdominis Plane (TAP) Block, Patient Control Analgesia (PCA)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transversus Abdominis Plane (TAP) Block Group
    Arm Type
    Active Comparator
    Arm Description
    Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly upto 24 hours.
    Arm Title
    Control Group (No TAP Block)
    Arm Type
    Placebo Comparator
    Arm Description
    The Transversus Abdominis Plane Block was not performed. Intravenous PCA Morphine was given as rescue analgesic upto 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine (Transversus Abdominis Plane Block)
    Intervention Description
    Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Patient Controlled Analgesia (PCA) Morphine
    Intervention Description
    PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Pain Score in PACU in Transversus Abdominis Plane Block and Control Patient Group.
    Description
    In the PACU Visual Analogue Pain Score will be noted at rest and on knee flexion up to 24 hours.
    Time Frame
    up to 24 hours
    Secondary Outcome Measure Information:
    Title
    Total and Good demands for PCA IV Morphine in milligrams in both the groups.
    Description
    In the PACU, Total and Good PCA IV Morphine demands in milligrams in both groups was studied.
    Time Frame
    up to 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients belonging to American Society of Anesthesiologist (ASA) Physical Status I to III, for Open lower abdominal major onco surgeries more than 2 hours duration. Exclusion Criteria: Patient refusal to participate in the study, allergy to local anesthetics, coagulopathy, local skin infection at the site of TAP Block.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anita Kulkarni, MD
    Organizational Affiliation
    Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India 110085
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19020158
    Citation
    Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
    Results Reference
    result
    PubMed Identifier
    17179269
    Citation
    McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
    Results Reference
    result

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    The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries

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