NCT02990884

Brief 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. aim of this study; Intra-operative anesthesia and analgesia effects of ilioinguinal / iliohyogogastric nerve block supported by ketamine sedation only.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 4, 2016

Last Update Submit

December 8, 2016

Conditions

Keywords

Intra-operative anesthesia and analgesiailioinguinal / iliohyogogastric nerve blockPediatric patient

Outcome Measures

Primary Outcomes (1)

  • the amount of anesthetic drug which was used

    nine month

Secondary Outcomes (1)

  • Postoperative visual analogue scale

    nine month

Study Arms (3)

block and ketamine

ACTIVE COMPARATOR

Ilioinguinal / iliohypogastric block after ketamine atropine induction and continued with ketamine only in anesthesia

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.

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

Drug: ketamine

Interventions

block and ketaminecontrol groupketamine atropine; laryngeal mask

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II
  • To undergo elective lower abdominal surgery
  • between 2-6 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Lacroix F. Epidemiology and morbidity of regional anaesthesia in children. Curr Opin Anaesthesiol. 2008 Jun;21(3):345-9. doi: 10.1097/ACO.0b013e3282ffabc5.

    PMID: 18458552BACKGROUND
  • 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.

    PMID: 18650577BACKGROUND
  • 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.

    PMID: 17767628BACKGROUND
  • 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.

    PMID: 23493806BACKGROUND
  • 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.

    PMID: 24841020BACKGROUND
  • 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.

    PMID: 22696610BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • ilke kupeli

    Erzincan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

December 4, 2016

First Posted

December 13, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share