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Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

Primary Purpose

Appendicitis Acute

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis Acute focused on measuring adult, appendectomy, appendicitis, local anesthesia, pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Including criteria:

  1. Clinical diagnosis of appendicitis and undergo laparoscopic appendectomy
  2. Age more than 20 years
  3. Well comprehensive in speaking Chinese

Exclusion criteria:

  1. Age no more than 20 years
  2. Pregnancy
  3. Can not cooperate with evaluation
  4. Convert to open surgical method, resect more organs than appendix
  5. Using patient control analgesia
  6. Allergy to local anesthetic agent

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wound with local anesthesia

Wound without local anesthesia

Arm Description

5 mL Bupivacaine is injected into subcutaneous area near surgical wound

Nothing is injected into subcutaneous area near surgical wound

Outcomes

Primary Outcome Measures

Pain score of surgical wound of the patient
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

Secondary Outcome Measures

Satisfaction of the patient
Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.

Full Information

First Posted
February 1, 2018
Last Updated
April 23, 2020
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03481517
Brief Title
Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult
Official Title
The Interest of Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult: a Double Blind, Prospective, Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
Keywords
adult, appendectomy, appendicitis, local anesthesia, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wound with local anesthesia
Arm Type
Experimental
Arm Description
5 mL Bupivacaine is injected into subcutaneous area near surgical wound
Arm Title
Wound without local anesthesia
Arm Type
No Intervention
Arm Description
Nothing is injected into subcutaneous area near surgical wound
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.
Primary Outcome Measure Information:
Title
Pain score of surgical wound of the patient
Description
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
Time Frame
within 24 hours after surgery
Secondary Outcome Measure Information:
Title
Satisfaction of the patient
Description
Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.
Time Frame
up to one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Yang Hsiao, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

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