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Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local infiltration and TAP block
local infiltration only
Sponsored by
Jubilee Mission Medical College and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Alveolar bone grafting, delirium, early ambulation

Eligibility Criteria

4 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must undergo alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate

Exclusion Criteria:

  • Revision procedure
  • History of difficulty in mentation and communication
  • Bleeding disorders, hepatic problems or renal dysfunction
  • Allergy to local anaesthetic
  • Presence of infection of anterior abdominal wall

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Local Infiltration with TAP block

    Local Infiltration only

    Arm Description

    Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.

    Local Infiltration with 0.2% Ropivacaine.

    Outcomes

    Primary Outcome Measures

    Mean pain scores
    Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
    Emergence delirium
    Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
    Pain scores
    Pain scores using the five - point verbal ranking score 24 hours after surgery
    Ambulatory status
    Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery

    Secondary Outcome Measures

    Infection and delayed healing at the graft harvest site
    All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
    Chronic pain, numbness or discomfort at graft harvest site
    All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest

    Full Information

    First Posted
    December 15, 2016
    Last Updated
    December 20, 2016
    Sponsor
    Jubilee Mission Medical College and Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02997124
    Brief Title
    Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?
    Official Title
    Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jubilee Mission Medical College and Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane block administered intraoperatively improves the postoperative parameters in patients undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if there is a decrease in the incidence of chronic pain or numbness at the harvest site.
    Detailed Description
    This study is a prospective, randomised, parallel group, single - centre trial evaluating the postoperative parameters in patients receiving supplemental Transversus Abdominis Plane block for anterior iliac crest harvest. It was conducted in 143 patients undergoing Alveolar bone grafting with iliac crest bone graft. Methodology: Informed consent and approval of local ethics and research committee in Jubilee Mission Medical College and Research Institute, Thrissur, India was obtained prior to initiation of the study. A pilot study was done to determine the efficacy of the additional TAP block. The results showed that the intervention improved patient analgesia and reduced the requirement for rescue analgesics. A minimum sample size of 65 patients was calculated for each group to obtain a power of 80% and confidence interval of 95%. 143 patients aged between 7 and 22 years posted for Alveolar bone grafting with anterior iliac crest harvest were assessed in the study. Only those undergoing Alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate were considered for the study. The patients who had difficulty in mentation and communication,bleeding disorders, hepatic problems, infection of the abdominal wall, renal dysfunction as well as allergy to the local anaesthetic were excluded from the study. Patients undergoing revision surgeries were also excluded from the study. All the candidates were randomly alloted to either of the two groups, using a computer - generated number. All the patients were premedicated with Midazolam 0.15mg kg-1 and Glycopyrolate 0.01mg kg-1 Anaesthesia was induced with Propofol 2 mg kg -1 and Fentanyl 2 mcg kg-1 .Vecuronium 0.1 mg kg-1 was given to facilitate orotracheal intubation with a cuffed tube.Anaesthesia was maintained with oxygen, nitrous oxide and sevoflurane. Prior to incision, all the patients were given wound infiltration with 0.75 ml kg-1 of 0.2% Ropivacaine at the graft harvest site. Those in group A received an additional ultrasound guided Transversus Abdominis Plane block with a similar volume and concentration of Ropivacaine. At the end of the surgical procedure, the patients were extubated awake, after giving I / V Neostigmine 0.05 mg kg-1. Just prior to extubation, I/V Tramadol 0.5 mg kg-1 was given for the pain in the postoperative period. In the recovery room, the pain and emergence delirium were assessed by an independent observer every ten minutes during the first postoperative hour.These were evaluated using the FLACC Behavioural Pain Assessment Scale and WATCHA Scale respectively. They were subsequently shifted to the postoperative ward. The next time point of assessment was 24 hours post - surgery, when the patient's pain and ambulatory status were evaluated. The pain was ranked using the five - point verbal ranking score. It was ranked as no pain, light pain, moderate pain, severe pain and intolerable pain, with a score of 0,1,2,3 and 4 respectively. The total number of rescue analgesics demanded by the patient on the first postoperative day was noted.Ambulatory status was graded using one - day Cumulated Ambulatory Score. The patients were followed up and questioned at six weeks and twelve weeks post operatively for the presence of chronic pain, numbness or wound healing problems at the harvest site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    Alveolar bone grafting, delirium, early ambulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    143 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Local Infiltration with TAP block
    Arm Type
    Experimental
    Arm Description
    Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.
    Arm Title
    Local Infiltration only
    Arm Type
    Experimental
    Arm Description
    Local Infiltration with 0.2% Ropivacaine.
    Intervention Type
    Procedure
    Intervention Name(s)
    local infiltration and TAP block
    Intervention Description
    Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
    Intervention Type
    Procedure
    Intervention Name(s)
    local infiltration only
    Intervention Description
    Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.
    Primary Outcome Measure Information:
    Title
    Mean pain scores
    Description
    Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
    Time Frame
    First hour after extubation
    Title
    Emergence delirium
    Description
    Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
    Time Frame
    First hour after extubation
    Title
    Pain scores
    Description
    Pain scores using the five - point verbal ranking score 24 hours after surgery
    Time Frame
    24 hours after surgery
    Title
    Ambulatory status
    Description
    Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
    Time Frame
    24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Infection and delayed healing at the graft harvest site
    Description
    All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
    Time Frame
    6 weeks after surgery
    Title
    Chronic pain, numbness or discomfort at graft harvest site
    Description
    All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest
    Time Frame
    12 weeks after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must undergo alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate Exclusion Criteria: Revision procedure History of difficulty in mentation and communication Bleeding disorders, hepatic problems or renal dysfunction Allergy to local anaesthetic Presence of infection of anterior abdominal wall
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vigil Peter, MD
    Organizational Affiliation
    Jubilee Mission Medical College and Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Citation
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