Intra-operative AnesthesiaNCT02990975
Transversus Abdominis Plane Block In Children
A study testing ketamine in people with Intra-operative Anesthesia, run by Erzincan University.
Trial summary
Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Intra-operative Anesthesia
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Sep 2017
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II
- To undergo elective lower abdominal surgery
- between 2-6 years old
Who cannot join
- Patients with psychiatric disease
- Patients whose weight is more than 40 kg
- Patients with cardiac-pulmonary-neurological disease
- Patients with bleeding disorder
- Patients with infection or scar on the injection area
- Patients with known allergies to local anesthetics
About this study
Official title: Effect of Ultrasonography Guided Transversus Abdominis Plane Block to Intraoperative Anesthesia in Children: Randomized Controlled Study
Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.
- Conditions
- Intra-operative Anesthesia
- Being tested
- ketamine
- Keywords
- Intra-operative anesthesia, Pediatric patient, Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
| Study group | Role | What they receive |
|---|---|---|
| block and ketamine | Active comparator | Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia Receives: Drug: ketamine |
| ketamine atropine; laryngeal mask | Active comparator | After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and applied Transversus Abdominis Plane block. Receives: Drug: ketamine |
| control group | Active comparator | After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of anesthetic drug which was used
Measured: two hour
Secondary outcomes (1)
Postoperative visual analogue scale
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intra-operative AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ilke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990975
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 7
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lacroix F. Epidemiology and morbidity of regional anaesthesia in children. Curr Opin Anaesthesiol. 2008 Jun;21(3):345-9. doi: 10.1097/ACO.0b013e3282ffabc5.
PubMed 18458552Willschke H, Marhofer P, Machata AM, Lonnqvist PA. Current trends in paediatric regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:97-104. doi: 10.1111/j.1365-2044.2010.06242.x.
PubMed 20377551Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24.
PubMed 22622954Schaeffer E, Millot I, Landy C, Nadaud J, Favier JC, Plancade D. Another use of continuous transversus abdominis plane (TAP) block in trauma patient: pelvic ring fractures. Pain Med. 2014 Jan;15(1):166-7. doi: 10.1111/pme.12029. Epub 2013 Jan 7. No abstract available.
PubMed 23294595Niraj G, Kelkar A, Fox AJ. Application of the transversus abdominis plane block in the intensive care unit. Anaesth Intensive Care. 2009 Jul;37(4):650-2. doi: 10.1177/0310057X0903700420.
PubMed 19681428Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.
PubMed 23389068Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
PubMed 23252578Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
PubMed 27366540
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasonography Guided Transversus Abdominis Plane Block to Intraoperative Anesthesia in Children: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02990975
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 7
- Conditions
- Intra-operative Anesthesia
- Keywords
- Intra-operative anesthesia, Pediatric patient, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| block and ketamine | Active comparator | Drug: ketamineTransversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia |
| ketamine atropine; laryngeal mask | Active comparator | Drug: ketamineAfter ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and applied Transversus Abdominis Plane block. |
| control group | Active comparator | Drug: ketamineAfter ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I-II
- To undergo elective lower abdominal surgery
- between 2-6 years old
Key exclusion criteria (6 listed)
- Patients with psychiatric disease
- Patients whose weight is more than 40 kg
- Patients with cardiac-pulmonary-neurological disease
- Patients with bleeding disorder
- Patients with infection or scar on the injection area
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 |
|---|---|---|
| ketamine | Drug | block and ketamine, control group, ketamine atropine; laryngeal mask |
Primary outcome
the amount of anesthetic drug which was used
Time frame: two hour
1 secondary outcome
Postoperative visual analogue scale
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Background: PubMed 18458552Lacroix F. Epidemiology and morbidity of regional anaesthesia in children. Curr Opin Anaesthesiol. 2008 Jun;21(3):345-9. doi: 10.1097/ACO.0b013e3282ffabc5.
- Background: PubMed 20377551Willschke H, Marhofer P, Machata AM, Lonnqvist PA. Current trends in paediatric regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:97-104. doi: 10.1111/j.1365-2044.2010.06242.x.
- Background: PubMed 22622954Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24.
- Background: PubMed 23294595Schaeffer E, Millot I, Landy C, Nadaud J, Favier JC, Plancade D. Another use of continuous transversus abdominis plane (TAP) block in trauma patient: pelvic ring fractures. Pain Med. 2014 Jan;15(1):166-7. doi: 10.1111/pme.12029. Epub 2013 Jan 7. No abstract available.
- Background: PubMed 19681428Niraj G, Kelkar A, Fox AJ. Application of the transversus abdominis plane block in the intensive care unit. Anaesth Intensive Care. 2009 Jul;37(4):650-2. doi: 10.1177/0310057X0903700420.
- Background: PubMed 23389068Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.
- Background: PubMed 23252578Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.
- Background: PubMed 27366540Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.
- 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.
ilke kupeli principal investigator
Erzincan University
Questions about this trial
What is this clinical trial studying?
A study testing ketamine in people with Intra-operative Anesthesia, run by Erzincan University.
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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
the amount of anesthetic drug which was used (time frame: two hour). 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 NCT02990975, which also lists 8 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 13 Dec 2016.