- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990884
Pediatric Ilioinguinal / Iliohyogogastric Nerve Block
December 8, 2016 updated by: ILKE KUPELI, Erzincan University
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-II
- To undergo elective lower abdominal surgery
- between 2-6 years old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: block and ketamine
Ilioinguinal / iliohypogastric block after ketamine atropine induction and continued with ketamine only in anesthesia
|
|
ACTIVE_COMPARATOR: ketamine atropine; laryngeal mask
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.
|
|
ACTIVE_COMPARATOR: control group
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the amount of anesthetic drug which was used
Time Frame: nine month
|
nine month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative visual analogue scale
Time Frame: nine month
|
nine month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bhattarai 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.
- Zanaboni 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.
- Abdellatif 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.
- Seyedhejazi 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.
- Polaner 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (ANTICIPATED)
July 1, 2017
Study Completion (ANTICIPATED)
September 1, 2017
Study Registration Dates
First Submitted
December 4, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (ESTIMATE)
December 13, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
December 13, 2016
Last Update Submitted That Met QC Criteria
December 8, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- ERZINCAN UNIVERSITY 6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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