Pain, PostoperativeNCT03969316
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block in The Pediatric Population Undergoing Orchiopexy
A study testing Transversus abdominis plane block, Quadratus lumborum block in people with Pain, Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years, men only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Transversus abdominis plane block, Quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2019to 13 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I-III
- Undergoing elective unilateral orchiopexy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul, 34100
About this study
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
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Transversus abdominis plane block, Quadratus lumborum block
- Keywords
- quadratus lumborum block, transversus abdominis plane block, pediatric patient, orchiopexy, regional anesthesia, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane block, Quadratus lumborum blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | 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. Receives: Procedure: Transversus abdominis plane block, Quadratus lumborum block |
| Transversus Abdominis Plane Block | Active comparator | 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. Receives: Procedure: Transversus abdominis plane block, Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Analgesia Consumption
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.
Measured: 24 hour
The Effect on Perioperative and Postoperative Pain
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.
Measured: 24 hour
The Effect on Post-discharge Pain
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.
Measured: 24 hour
Secondary outcomes (1)
Parent satisfaction score
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)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start10 May 2019
- Primary completion18 Dec 2020
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgecan Piril Zanbak, Istanbul University - Cerrahpasa
- Investigators
- Ozgecan P Zanbak, MD, Principal investigator, Istanbul University - CerrahpasaAyse C Tutuncu, MD,Prof, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969316
- Sponsor's protocol ID
- 71381
- Status last verified
- Jun 2021
- First submitted
- 29 May 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PubMed 28759502Mutlu OPZ, Tutuncu AC, Kendigelen P, Kara Esen B. Posterior transversus abdominis plane block versus lateral quadratus lumborum block in children undergoing open orchiopexy: a randomized clinical trial☆. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744443. doi: 10.1016/j.bjane.2023.06.004. Epub 2023 Jul 8.
PubMed 37429376
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03969316
- Acronym / sponsor ID
- 71381
- Conditions
- Pain, Postoperative
- Keywords
- quadratus lumborum block, transversus abdominis plane block, pediatric patient, orchiopexy, regional anesthesia, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | Procedure: Transversus abdominis plane block, Quadratus lumborum blockAfter 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. |
| Transversus Abdominis Plane Block | Active comparator | Procedure: Transversus abdominis plane block, Quadratus lumborum blockAfter 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. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status I-III
- Undergoing elective unilateral orchiopexy
Key exclusion criteria (6 listed)
- Not giving a consent
- ASA physical status IV
- Need to postoperative ICU care
- History of allergic reactions to anesthetics
- Infection at the injection site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus abdominis plane block, Quadratus lumborum blockThe 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. | Procedure or surgery | Quadratus Lumborum Block, Transversus Abdominis Plane Block |
Primary outcome
Total Analgesia Consumption
Time frame: 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.
The Effect on Perioperative and Postoperative Pain
Time frame: 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.
The Effect on Post-discharge Pain
Time frame: 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.
1 secondary outcome
Parent satisfaction score
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Background: PubMed 28759502Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
- Derived from this study: PubMed 37429376Mutlu OPZ, Tutuncu AC, Kendigelen P, Kara Esen B. Posterior transversus abdominis plane block versus lateral quadratus lumborum block in children undergoing open orchiopexy: a randomized clinical trial☆. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744443. doi: 10.1016/j.bjane.2023.06.004. Epub 2023 Jul 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgecan P Zanbak, MD principal investigator
Istanbul University - Cerrahpasa
Ayse C Tutuncu, MD,Prof study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block, Quadratus lumborum block in people with Pain, Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Analgesia Consumption (time frame: 24 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969316, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.