Postoperative PainNCT03463382
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children
A study testing Erector Spinae Plane Block, Quadratus Lumborum Block and Bupivacaine (Block Drug) in people with Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block, Quadratus Lumborum Block and Bupivacaine (Block Drug)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2018to 1 Nov 2018
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-7 years of age
- ASA I-II
- Undergoing elective low abdominal surgery
Who cannot join
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- ASA III-IV
- Patients with neurological disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Hospital
İzmit, Kocaeli, 41340
About this study
Official title: Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial
Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Quadratus Lumborum Block, Bupivacaine (Block Drug)
- Keywords
- Pediatric Surgery, Postoperative Pain, Erector spinae plane block, quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector Spinae Plane block will be administered under general anesthesia before the surgery
Quadratus Lumborum BlockProcedure or surgery
Quadratus Lumborum Block will be administered under general anesthesia before the surgery
Bupivacaine (Block Drug)Drug
0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances
| Study group | Role | What they receive |
|---|---|---|
| ESP Group | Active comparator | Erector Spinae Plane Block Group
Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks Receives: Procedure: Erector Spinae Plane Block; Drug: Bupivacaine (Block Drug) |
| QLB Group | Active comparator | Quadratus Lumborum Block Group
Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks Receives: Procedure: Quadratus Lumborum Block; Drug: Bupivacaine (Block Drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Postoperative first 6hours
Secondary outcomes (2)
Time to first analgesic drug
Time to first analgesic drug will be recorded
Measured: first 48 hour
Need for analgesic
Number of patients who required analgesic in the first 24 hour
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 posted13 Mar 2018
- Study start12 Mar 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463382
- Sponsor's protocol ID
- 2018-95
- Status last verified
- Nov 2018
- First submitted
- 28 Feb 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
PubMed 30851499
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03463382
- Acronym / sponsor ID
- 2018-95
- Conditions
- Postoperative Pain
- Keywords
- Pediatric Surgery, Postoperative Pain, Erector spinae plane block, quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 13 Mar 2018 (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.
Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Group | Active comparator | Procedure: Erector Spinae Plane Block, Drug: Bupivacaine (Block Drug)Erector Spinae Plane Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks |
| QLB Group | Active comparator | Procedure: Quadratus Lumborum Block, Drug: Bupivacaine (Block Drug)Quadratus Lumborum Block Group Block Drug: 0,25% bupivacaine 0,5ml/kg (max.20ml) were used for blocks |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1-7 years of age
- ASA I-II
- Undergoing elective low abdominal surgery
Key exclusion criteria (5 listed)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- ASA III-IV
- Patients with neurological disorders
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 |
|---|---|---|
| Erector Spinae Plane BlockErector Spinae Plane block will be administered under general anesthesia before the surgery | Procedure or surgery | ESP Group |
| Quadratus Lumborum BlockQuadratus Lumborum Block will be administered under general anesthesia before the surgery | Procedure or surgery | QLB Group |
| Bupivacaine (Block Drug)0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances | Drug | ESP Group, QLB Group |
Primary outcome
Pain scores
Time frame: Postoperative first 6hours
FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
2 secondary outcomes
Time to first analgesic drug
Time frame: first 48 hour
Need for analgesic
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 14 Nov 2018.
- Derived from this study: PubMed 30851499Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block, Quadratus Lumborum Block and Bupivacaine (Block Drug) in people with Postoperative Pain, run by Kocaeli University 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 3 inclusion and 5 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 14 Nov 2018. 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?
Pain scores (time frame: Postoperative first 6hours). 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 NCT03463382, which also lists 1 linked publication.
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 14 Nov 2018.