NCT02115087

Brief Summary

The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

April 9, 2014

Last Update Submit

April 14, 2014

Conditions

Keywords

laparotomylevobupivacainepatient controlled analgesia

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the FLACC scale

    FLACC scale has been used to measure postoperative pain level in children

    Twenty-four hours

Study Arms (2)

ultrasound guided rectus sheath block

EXPERIMENTAL

Ultrasound guided rectus sheath block

Procedure: ultrasound guided rectus sheath block

iv morphine

ACTIVE COMPARATOR

0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period

Drug: Morphine

Interventions

the application of rectus sheath block with ultrasound guidance

Also known as: US guided rectus sheath block
ultrasound guided rectus sheath block
iv morphine

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I-II
  • years of age children
  • Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision

You may not qualify if:

  • ASA physical status III and above
  • Parents who did not consider to participate in the study
  • Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Cukurova University Faculty of Medicine

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (1)

  • Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.

    PMID: 21377070BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Dilek Ozcengiz, Prof.

    Department of Anesthesiology, Cukurova University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 15, 2014

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations