NCT01997593

Brief Summary

The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

October 27, 2013

Last Update Submit

March 25, 2015

Conditions

TesticularColic

Keywords

analgesiapediatricpainlaparoscopyropivacaine

Outcome Measures

Primary Outcomes (1)

  • pain score

    within the first 2days after the surgery

Secondary Outcomes (4)

  • Analgesic dose

    Within the first 2days after the surgery

  • Gastrointestinal function recovery score

    Within the first 2days after the surgery

  • Wound score

    Within the first 2days after the surgery

  • Time to discharge

    Participants will be followed for the duration of hospital stay, an expected average of 2weeks

Study Arms (1)

ropivacaine

EXPERIMENTAL

Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery.

Drug: intraperitoneal infiltration of ropivacaine

Interventions

intraperitoneal infiltration of ropivacaineDRUG

intraperitoneal infiltration of ropivacaine by a special equipment

ropivacaine

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between 6 months and 5years.
  • Laparoscopic inguinal hernia repair
  • Laparoscopic testicular descent fixation

You may not qualify if:

  • Patient who are suffering from mental disease
  • Patient who suffering from neuromuscular disease
  • Local anesthetic allergy
  • Patient who needs directly into ICU after the operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

ColicAgnosiaPain

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yang Hui, Professor

    China Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 28, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

CN(1)