Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

Phase 4

Completed

• Conditions: Appendicitis Acute
• Interventions: Drug: Bupivacaine

• Registration Number: NCT03481517
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Study Start: 2018-04-23
• Primary Completion: 2019-07-08
• Study Completion: 2019-07-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound with local anesthesia	Bupivacaine	5 mL Bupivacaine is injected into subcutaneous area near surgical wound

Primary Outcome Measures

Name	Time	Method
Pain score of surgical wound of the patient	within 24 hours after surgery	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

Name	Time	Method
Satisfaction of the patient	up to one month after surgery	Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan