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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03481517
Other study ID # 201710064RINB
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 23, 2018
Est. completion date July 31, 2019

Study information

Verified date April 2020
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date July 31, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine
Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 within 24 hours after surgery
Secondary Satisfaction of the patient Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization. up to one month after surgery
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