Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

March 25, 2015 updated by: Ping Yang

Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
  2. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
  3. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources .
  4. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information .
  5. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
  6. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
  7. Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
  8. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between 6 months and 5years.
  2. Laparoscopic inguinal hernia repair
  3. Laparoscopic testicular descent fixation

Exclusion Criteria:

  1. Patient who are suffering from mental disease
  2. Patient who suffering from neuromuscular disease
  3. Local anesthetic allergy
  4. Patient who needs directly into ICU after the operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ropivacaine
Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery.
Drug: intraperitoneal infiltration of ropivacaine
intraperitoneal infiltration of ropivacaine by a special equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain score
Time Frame: within the first 2days after the surgery
within the first 2days after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Analgesic dose
Time Frame: Within the first 2days after the surgery
Within the first 2days after the surgery
Gastrointestinal function recovery score
Time Frame: Within the first 2days after the surgery
Within the first 2days after the surgery
Wound score
Time Frame: Within the first 2days after the surgery
Within the first 2days after the surgery
Time to discharge
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks
Participants will be followed for the duration of hospital stay, an expected average of 2weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ping Yang

Investigators

  • Study Director: Yang Hui, Professor, China Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 27, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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