Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

Study Overview
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Brief Summary
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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.

Official Title
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The Interest of Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult: a Double Blind, Prospective, Randomized Control Trial

Conditions
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Appendicitis Acute

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound with local anesthesia<br>5 mL Bupivacaine is injected into subcutaneous area near surgical wound | Drug: Bupivacaine<br>* Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.<br>* Other names: Marcaine;|
| No Intervention: Wound without local anesthesia<br>Nothing is injected into subcutaneous area near surgical wound | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of the patient | Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization. | up to one month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, adult, appendectomy, appendicitis, local anesthesia