NCT02990975

Brief Summary

Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane 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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month 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

8 months

First QC Date

December 4, 2016

Last Update Submit

December 8, 2016

Conditions

Intra-operative Anesthesia

Keywords

Intra-operative anesthesiaPediatric patientTransversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • the amount of anesthetic drug which was used

    two hour

Secondary Outcomes (1)

  • Postoperative visual analogue scale

    one day

Study Arms (3)

block and ketamine

ACTIVE COMPARATOR

Transversus Abdominis Plane 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 Transversus Abdominis Plane 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

ketamineDRUG
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 (8)

  • 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

  • Willschke 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.

    PMID: 20377551BACKGROUND

  • Mishriky 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.

    PMID: 22622954BACKGROUND

  • Schaeffer 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.

    PMID: 23294595BACKGROUND

  • Niraj 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.

    PMID: 19681428BACKGROUND

  • Walter 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.

    PMID: 23389068BACKGROUND

  • 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

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

September 1, 2017

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share