Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Tongji Hospital
Sponsor:
Information provided by (Responsible Party):
Ping Yang, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT01997593
First received: October 27, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Testicular
Colic
Drug: intraperitoneal infiltration of ropivacaine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Tongji Hospital:

Primary Outcome Measures:
  • pain score [ Time Frame: within the first 2days after the surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesic dose [ Time Frame: Within the first 2days after the surgery ] [ Designated as safety issue: No ]
  • Gastrointestinal function recovery score [ Time Frame: Within the first 2days after the surgery ] [ Designated as safety issue: No ]
  • Wound score [ Time Frame: Within the first 2days after the surgery ] [ Designated as safety issue: No ]
  • Time to discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ropivacaine
Preincisional wound intraperitoneal infiltration of 0.5% ropivacaine 0.25ml/kg was performed in group I patients before surgery.
Drug: intraperitoneal infiltration of ropivacaine

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
  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997593

Locations
China, Hubei
Tongji Hospital Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Yang ping, master    8613419518289    janeyp@sina.cn   
Principal Investigator: Yang ping, Master         
Sponsors and Collaborators
Ping Yang
Investigators
Study Director: Yang Hui, Professor China Tongji Hospital
  More Information

No publications provided

Responsible Party: Ping Yang, Principal Investigator, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01997593     History of Changes
Other Study ID Numbers: 20130801
Study First Received: October 27, 2013
Last Updated: November 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Tongji Hospital:
analgesia
pediatric
pain
laparoscopy
ropivacaine

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014