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

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Completed
CT.gov ID
NCT03969316
Collaborator
(none)
102
1
2
22.1
4.6

Study Details

Study Description

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 elective orchiopexy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversus abdominis plane block, Quadratus lumborum block
N/A

Detailed Description

American Society of Anesthesiologists Physical Status Classification System (ASA) class I-III, aged 6 month-12 years old children undergoing unilateral 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 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. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both group.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 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
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Mar 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Quadratus Lumborum Block

After the premedication with ketamine and 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. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound at the anterolateral border of quadratus lumborum muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.

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 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. 0.4 ml/kg %0.25 bupivacaine will be used as a local anesthetic agent in both groups and the local anesthetic agent will be administrated with ultrasound between internal oblique and transversus abdominis muscle with 18, 20 or 22 Gauge IV Cannula (Bicakcilar Cooperation, Istanbul, Turkey) according to age and body weight.

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.

Outcome Measures

Primary Outcome Measures

  1. Total Analgesia Consumption [24 hour]

    The required analgesic consumption within the framework of the predetermined protocol will be recorded by the nurses and doctors who do not know which block is used. After discharge, the family will be called by phone to find out the amount of additional analgesic need.

  2. The Effect on Perioperative and Postoperative Pain [24 hour]

    The investigator will screen and record perioperative hemodynamic parameters for the perioperative pain evaluation. The Face, Legs, Activity, Cry, Consobility (FLACC) Score will be used for evaluation of the postoperative pain. The FLACC pain assessment score is evaluated out of 10 points. While a score of zero defined as no pain, 1-3 is mild pain, 4-6 is moderate pain, 7-10 is severe pain, respectively. If the score is 4 and above, additional analgesic administration will be planned.

  3. The Effect on Post-discharge Pain [24 hour]

    Post-discharge pain will be assessed by the Wong Baker Score. Pain will be evaluated based on six facial expressions between zero and ten points. If the score is four or more, additional analgesic administration will be planned.

Secondary Outcome Measures

  1. Parent satisfaction score [24 hour]

    At the postoperative 24th hour, the investigator will ask to the parents by telephone visit. Parent satisfaction score is defined as unsatisfied (1), partially satisfied (2), satisfied (3)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 12 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA physical status I-III

  • Undergoing elective unilateral 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

  • Laparoscopic Orchiopexy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University - Cerrahpasa Istanbul Turkey 34100

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

  • Principal Investigator: Ozgecan P Zanbak, MD, Istanbul University-Cerrahpasa
  • Study Chair: Ayse C Tutuncu, MD,Prof, Istanbul University-Cerrahpasa

Study Documents (Full-Text)

None provided.

More Information

Publications

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
Last Update Posted:
Jun 8, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozgecan Piril Zanbak, Resident Medical Doctor, Anesthesiology and Reanimation Department, Istanbul University-Cerrahpasa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2021