- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481517
Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult
April 23, 2020 updated by: National Taiwan University Hospital
The Interest of Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult: a Double Blind, Prospective, Randomized Control Trial
Acute appendicitis is one of the most common acute abdomens that need surgical intervention.
Laparoscopic surgery much decreases postoperative pain of wound, however, pain remains an important determinant of recovery after surgery.
Intraoperative local anesthetic agent infiltrated locally into surgical wound to relieve postoperative pain is a feasible and safe method suggested in some literature.
However, there is no routine use of this method in clinical practice because its benefit is still unknown.
Besides, very few evidence could be found in literature review.
To date, there is still no double blinded, prospective, randomized control trial addressing in evaluation of its interest.
In this study, the investigators aim at investigating the benefit of wound infiltration with local anesthetic agent (bupivacaine) for laparoscopic appendectomy in adult.
The study design is a double blind, prospective, randomized control trial with a 1:1 allocation ratio.
Fifty adult patients with appendicitis will be included.
The control group undergo laparoscopic appendectomy without wound infiltration with local anesthetic agent, the intervention group undergo laparoscopic appendectomy with wound infiltration with local anesthetic agent intraoperatively.
The clinical characteristics, outcomes, and patient's satisfaction will be recorded and analyzed.
The investigators hope this study can provide a high level evidence in pain management of patient undergo laparoscopic surgery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 4
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
-
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Including criteria:
- Clinical diagnosis of appendicitis and undergo laparoscopic appendectomy
- Age more than 20 years
- Well comprehensive in speaking Chinese
Exclusion criteria:
- Age no more than 20 years
- Pregnancy
- Can not cooperate with evaluation
- Convert to open surgical method, resect more organs than appendix
- Using patient control analgesia
- Allergy to local anesthetic agent
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wound with local anesthesia
5 mL Bupivacaine is injected into subcutaneous area near surgical wound
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Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.
Other Names:
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No Intervention: Wound without local anesthesia
Nothing is injected into subcutaneous area near surgical wound
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score of surgical wound of the patient
Time Frame: within 24 hours after surgery
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Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient
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within 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of the patient
Time Frame: up to one month after surgery
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Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.
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up to one month after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chih-Yang Hsiao, M.D., National Taiwan University 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 (Actual)
April 23, 2018
Primary Completion (Actual)
July 8, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
March 27, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2020
Last Update Submitted That Met QC Criteria
April 23, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Cecal Diseases
- Intraabdominal Infections
- Appendicitis
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 201710064RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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