NCT02991053

Brief Summary

the aim of this study is to compare the effects of Transversus abdominis plane block and ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the anesthesia and analgesia contributions during surgery without general anesthesia.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 4, 2016

Last Update Submit

December 8, 2016

Conditions

Keywords

Intra-operative anesthesiaPediatric patientTransversus Abdominis Plane Blockilioinguinal / iliohypogastric nerve block

Outcome Measures

Primary Outcomes (1)

  • Amount of anesthetic drug which was used

    2 hour

Secondary Outcomes (1)

  • Postoperative visual analogue scale

    one day

Study Arms (5)

block and ketamine

ACTIVE COMPARATOR

Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia

Drug: ketamine

block; ketamine with laryngeal mask; inhalation anesthesia

ACTIVE COMPARATOR

After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration and oxygen / air mixture and applied Transversus Abdominis Plane block.

Drug: ketamine

block and ketamine ıh/ıl

ACTIVE COMPARATOR

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

Drug: ketamine

ıh/ıl block; ketamine; inhalation anesthesia

ACTIVE COMPARATOR

After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane minimum alveolar concentration 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 minimum alveolar concentration and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV

Drug: ketamine

Interventions

block and ketamineblock and ketamine ıh/ılblock; ketamine with laryngeal mask; inhalation anesthesiacontrol groupıh/ıl block; ketamine; inhalation anesthesia

Eligibility Criteria

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

You may qualify if:

  • American society of anesthesia score 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 (7)

  • Newman K, Ponsky T, Kittle K, Dyk L, Throop C, Gieseker K, Sills M, Gilbert J. Appendicitis 2000: variability in practice, outcomes, and resource utilization at thirty pediatric hospitals. J Pediatr Surg. 2003 Mar;38(3):372-9; discussion 372-9. doi: 10.1053/jpsu.2003.50111.

    PMID: 12632352BACKGROUND
  • Scott AD, Phillips A, White JB, Stow PJ. Analgesia following inguinal herniotomy or orchidopexy in children: a comparison of caudal and regional blockade. J R Coll Surg Edinb. 1989 Jun;34(3):143-5.

    PMID: 2810163BACKGROUND
  • Markham SJ, Tomlinson J, Hain WR. Ilioinguinal nerve block in children. A comparison with caudal block for intra and postoperative analgesia. Anaesthesia. 1986 Nov;41(11):1098-103. doi: 10.1111/j.1365-2044.1986.tb12956.x.

    PMID: 3789367BACKGROUND
  • Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.

    PMID: 20857679BACKGROUND
  • Stuart-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.

    PMID: 23252578BACKGROUND
  • Tekelioglu 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.

    PMID: 27366540BACKGROUND
  • 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

Interventions

Ketamine

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

August 1, 2017

Study Completion

November 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share