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Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

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ClinicalTrials.gov Identifier: NCT02723487
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

Brief Summary:
The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine 0.125% Drug: Bupivacaine 0.25% Phase 2

Detailed Description:

A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.

After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.

After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .

Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.

The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery
Actual Study Start Date : April 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group A
Control
Active Comparator: Group B
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
Drug: Bupivacaine 0.125%
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.
Other Name: Plain marcaine

Active Comparator: Group C
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
Drug: Bupivacaine 0.25%
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.
Other Name: Plain marcaine




Primary Outcome Measures :
  1. pain score [ Time Frame: 12 hours postoperative ]
    Children's Hospital Eastern Ontario Pain Scale


Secondary Outcome Measures :
  1. Total intraoperative fentanyl consumption [ Time Frame: 12 hours postoperative ]
    Microgram (ug)

  2. number of participants with incidence of nausea [ Time Frame: 12 hours postoperative ]
    number of patients

  3. number of participants with incidence of hematoma [ Time Frame: 12 hours postoperative ]
    number of patients

  4. number of participants with incidence of infection [ Time Frame: 12 hours postoperative ]
    number of patients

  5. Total postoperative paracetamol consumption [ Time Frame: 12 hours postoperative ]
    Milligram (mg)

  6. Number of participants with incidence of vomiting [ Time Frame: 12 hours postoperative ]
    number of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   According to type of surgery laparoscopic undescended testis
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II physical status patients.
  • Genders Eligible for Study :male.
  • All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
  • Duration of Laparoscopic procedure not exceeding 90 minutes.
  • Written informed consent from parent of guardian .

Exclusion Criteria:

  • Sensitivities to local anesthetics.
  • Significant renal, liver, or cardiac disease.
  • Surgery requiring an open procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723487


Locations
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Egypt
Assiut university faculty of medicine
Assiut, Egypt
Sponsors and Collaborators
Abdelrady S Ibrahim, MD
Investigators
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Principal Investigator: Abdelrady s Ibrahim, MD Assistant profossor

Publications:
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Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of Anesthesia and Intensive care, Assiut University
ClinicalTrials.gov Identifier: NCT02723487     History of Changes
Other Study ID Numbers: 17100390
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Abdelrady S Ibrahim, MD, Assiut University:
TAP block
pediatric
Laparoscopic
postoperative pain

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents