Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

National Taiwan University

Status and phase: Completed; Phase 4

Conditions: Appendicitis Acute

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03481517

201710064RINB

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

Wound with local anesthesia

Experimental group

Description:

5 mL Bupivacaine is injected into subcutaneous area near surgical wound

Treatment:

Drug: Bupivacaine

Wound without local anesthesia

No Intervention group

Description:

Nothing is injected into subcutaneous area near surgical wound