Intra-operative Anesthesia and Analgesia EffectsNCT02990884
Pediatric Ilioinguinal / Iliohyogogastric Nerve Block
A study testing ketamine in people with Intra-operative Anesthesia and Analgesia Effects, run by Erzincan University.
Trial summary
Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Intra-operative Anesthesia and Analgesia Effects
- 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: Influence of Ultrasonography Guided Ilioinguinal / Iliohipogastric Block in Intraoperative Anesthesia in Children - Randomized Controlled Study
Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general anesthesia. aim of this study; Intra-operative anesthesia and analgesia effects of ilioinguinal / iliohyogogastric nerve block supported by ketamine sedation only.
- Being tested
- ketamine
- Keywords
- Intra-operative anesthesia and analgesia, ilioinguinal / iliohyogogastric nerve block, Pediatric patient
- Medical subject headings
- Agnosia
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 | Ilioinguinal / iliohypogastric 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 Ilioinguinal / iliohypogastric 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: nine month
Secondary outcomes (1)
Postoperative visual analogue scale
Measured: nine month
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 completionJul 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 (6)Papers the sponsor has linked to this study.
- Other trials for Intra-operative Anesthesia and Analgesia EffectsStudies 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
- NCT02990884
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 6
- 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 18458552Bhattarai BK, Rahman TR, Sah BP, Tuladhar UR. Analgesia after inguinal herniotomy in children: combination of simplified (Single Puncture) ilioinguinal and iliohypogastric nerve blocks and wound infiltration vs. caudal block with 0.25% bupivacaine. Kathmandu Univ Med J (KUMJ). 2005 Jul-Sep;3(3):208-11.
PubMed 18650577Zanaboni S, Krauss B, Buscaglia R, Montagnini C, Gratarola A, Gualino J, Colombo R, Della Corte F. Changes in respiratory and hemodynamic parameters during low-dose propofol sedation in combination with regional anesthesia for herniorrhaphy and genitourinary surgery in children. Paediatr Anaesth. 2007 Oct;17(10):934-41. doi: 10.1111/j.1460-9592.2007.02299.x.
PubMed 17767628Abdellatif AA. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block for postoperative analgesia in children undergoing unilateral groin surgery. Saudi J Anaesth. 2012 Oct-Dec;6(4):367-72. doi: 10.4103/1658-354X.105868.
PubMed 23493806Seyedhejazi M, Sheikhzadeh D, Adrang Z, Rashed FK. Comparing the analgesic effect of caudal and ilioinguinal iliohypogastric nerve blockade using bupivacaine-clonidine in inguinal surgeries in children 2-7 years old. Afr J Paediatr Surg. 2014 Apr-Jun;11(2):166-9. doi: 10.4103/0189-6725.132821.
PubMed 24841020Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.
PubMed 22696610
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
- Influence of Ultrasonography Guided Ilioinguinal / Iliohipogastric Block in Intraoperative Anesthesia in Children - Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02990884
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 6
- Keywords
- Intra-operative anesthesia and analgesia, ilioinguinal / iliohyogogastric nerve block, Pediatric patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 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.
Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general anesthesia. aim of this study; Intra-operative anesthesia and analgesia effects of ilioinguinal / iliohyogogastric nerve 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: ketamineIlioinguinal / iliohypogastric 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 Ilioinguinal / iliohypogastric 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: nine month
1 secondary outcome
Postoperative visual analogue scale
Time frame: nine month
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 18650577Bhattarai BK, Rahman TR, Sah BP, Tuladhar UR. Analgesia after inguinal herniotomy in children: combination of simplified (Single Puncture) ilioinguinal and iliohypogastric nerve blocks and wound infiltration vs. caudal block with 0.25% bupivacaine. Kathmandu Univ Med J (KUMJ). 2005 Jul-Sep;3(3):208-11.
- Background: PubMed 17767628Zanaboni S, Krauss B, Buscaglia R, Montagnini C, Gratarola A, Gualino J, Colombo R, Della Corte F. Changes in respiratory and hemodynamic parameters during low-dose propofol sedation in combination with regional anesthesia for herniorrhaphy and genitourinary surgery in children. Paediatr Anaesth. 2007 Oct;17(10):934-41. doi: 10.1111/j.1460-9592.2007.02299.x.
- Background: PubMed 23493806Abdellatif AA. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block for postoperative analgesia in children undergoing unilateral groin surgery. Saudi J Anaesth. 2012 Oct-Dec;6(4):367-72. doi: 10.4103/1658-354X.105868.
- Background: PubMed 24841020Seyedhejazi M, Sheikhzadeh D, Adrang Z, Rashed FK. Comparing the analgesic effect of caudal and ilioinguinal iliohypogastric nerve blockade using bupivacaine-clonidine in inguinal surgeries in children 2-7 years old. Afr J Paediatr Surg. 2014 Apr-Jun;11(2):166-9. doi: 10.4103/0189-6725.132821.
- Background: PubMed 22696610Polaner DM, Taenzer AH, Walker BJ, Bosenberg A, Krane EJ, Suresh S, Wolf C, Martin LD. Pediatric Regional Anesthesia Network (PRAN): a multi-institutional study of the use and incidence of complications of pediatric regional anesthesia. Anesth Analg. 2012 Dec;115(6):1353-64. doi: 10.1213/ANE.0b013e31825d9f4b. Epub 2012 Jun 13.
- Individual participant dataSharing planned: No
Related trials for Intra-operative Anesthesia and Analgesia Effects
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Intraoperative Music and Propofol Consumption in Breast Surgery
Anesthesia , Analgesia, Breast Surgery
RecruitingObservational study
Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
Lumbar Spinal Stenosis, Lumbar Disc Herniation With Radiculopathy
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 and Analgesia Effects, 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: nine month). 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 NCT02990884, which also lists 6 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.