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Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy

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ClinicalTrials.gov Identifier: NCT03969316
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ozgecan Piril Zanbak, Istanbul University-Cerrahpasa

Brief Summary:

Transversus abdominis plane (TAP) and Quadratus lumborum (QL) blocks are used for the management of acute pain treatment, especially after the lower and upper abdominal surgeries.

The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.

The investigators' aim in this study, to investigate the effect of the TAP and QL blocks on peroperative and postoperative analgesic consumption in children undergoing unilateral or bilateral elective orchiopexy.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Transversus abdominis plane block, Quadratus lumborum block Not Applicable

Detailed Description:

American Society of Anesthesiologists Physical Status Classification System (ASA) class I-III, aged 1-10 years children undergoing unilateral or bilateral elective orchiopexy with general anesthesia will be recruited, after the informed consent will be obtained from the parents of the patients, in this randomized controlled trial.

After the premedication with ketamine and/or midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane.

Subsequently, before the surgery, the patients will be randomized and separated into 2 groups. The investigators will apply the QL block to the first group and TAP block to the other group. If the patient has the unilateral undescended testis, 0.4 ml/kg %0.25 bupivacaine, if the patient has the bilateral one, in every side 0.2ml/kg %0.25 bupivacaine will be administrated in both groups.

In the peroperative period, if the additional analgesia will necessary, remifentanyl 0.1mcg/kg/min will be started, and dosage will be adjusted according to heart rate and blood pressure. If the blood pressure or heart rate will increase more than 20% from the preoperative basal value will be defined as the need for the analgesia.

In the postoperative period, all cohort will be assessed by a blinded investigator at the 10,20,30th minutes, 1,2nd hours in the recovery room, 6th hour in the surgical ward, Face, Legs, Activity, Cry, Consolability Scale (FLACC) will be used for the pain evaluation. 16th and 24th hours will be monitored by the telephone visit from the parents, the pain will be evaluated with the Wong-Baker Faces Pain Rating Scale due to the same-day surgery concept.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Comparison of Ultrasound-Guided Transversus Abdominis Plane Block and Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy. A Randomized Controlled Trial
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : August 10, 2020

Arm Intervention/treatment
Active Comparator: Quadratus Lumborum Block
After the premedication with ketamine and/or midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane.If the patient has the unilateral undescended testis, 0.4 ml/kg %0.25 bupivacaine, if the patient has the bilateral one, in every side 0.2ml/kg %0.25 bupivacaine will be administrated with ultrasound at the posterior border of quadratus lumborum muscle with Stimuplex needle (BBraun, Melsungen, Germany).
Procedure: Transversus abdominis plane block, Quadratus lumborum block
The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.

Active Comparator: Transversus Abdominis Plane Block
After the premedication with ketamine and/or midazolam will be performed, the patient will be brought to the operation room. After the induction with thiopental 5mg/kg, fentanyl 1mcg/kg, rocuronium 0.6mg/kg, patients will be intubated. The maintenance of the anesthesia will be provided with sevoflurane.If the patient has the unilateral undescended testis, 0.4 ml/kg %0.25 bupivacaine, if the patient has the bilateral one, in every side 0.2ml/kg %0.25 bupivacaine will be administrated with ultrasound between internal oblique and transversus abdominis muscle with Stimuplex needle (BBraun, Melsungen, Germany).
Procedure: Transversus abdominis plane block, Quadratus lumborum block
The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.




Primary Outcome Measures :
  1. Total Analgesia Consumption [ Time Frame: 24 hour ]
    The investigator will screen before the hospital discharge, then wıth the telephone visit to parents


Secondary Outcome Measures :
  1. Parent satisfaction score [ Time Frame: 24 hour ]
    At the postoperative 24th hour, the investigator will ask to the parents

  2. First analgesic using time [ Time Frame: 24 hour ]
    The investigator will screen before the hospital discharge, then wıth the telephone visit to parents



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III
  • Undergoing elective unilateral or bilateral orchiopexy

Exclusion Criteria:

  • Not giving a consent
  • ASA physical status IV
  • Need to postoperative ICU care
  • History of allergic reactions to anesthetics
  • Infection at the injection site

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): NCT03969316


Contacts
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Contact: Ozgecan P Zanbak, MD +905376670310 pirilz@hotmail.com

Locations
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Turkey
Istanbul University - Cerrahpasa Recruiting
Istanbul, Turkey, 34100
Contact: Ayse C Tutuncu, MD, Prof    +905325920584    actutuncu@gmail.com   
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Ozgecan P Zanbak, MD Istanbul University-Cerrahpasa
Study Chair: Ayse C Tutuncu, MD,Prof Istanbul University-Cerrahpasa

Publications:
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Responsible Party: Ozgecan Piril Zanbak, Resident Medical Doctor, Anesthesiology and Reanimation Department, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT03969316    
Other Study ID Numbers: 71381
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozgecan Piril Zanbak, Istanbul University-Cerrahpasa:
quadratus lumborum block
transversus abdominis plane block
pediatric patient
orchiopexy
regional anesthesia
pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs