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Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

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ClinicalTrials.gov Identifier: NCT01997593
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Ping Yang, Tongji Hospital

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

Condition or disease Intervention/treatment Phase
Testicular Colic Drug: intraperitoneal infiltration of ropivacaine Phase 2

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  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
Study Start Date : November 2013
Primary Completion Date : May 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. pain score [ Time Frame: within the first 2days after the surgery ]

Secondary Outcome Measures :
  1. Analgesic dose [ Time Frame: Within the first 2days after the surgery ]
  2. Gastrointestinal function recovery score [ Time Frame: Within the first 2days after the surgery ]
  3. Wound score [ Time Frame: Within the first 2days after the surgery ]
  4. Time to discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997593

China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Ping Yang
Study Director: Yang Hui, Professor China Tongji Hospital

Responsible Party: Ping Yang, Principal Investigator, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01997593     History of Changes
Other Study ID Numbers: 20130801
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Ping Yang, Tongji Hospital:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents