Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2019-07-31

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.

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Detailed Description

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Conditions

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Appendicitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Wound with local anesthesia

5 mL Bupivacaine is injected into subcutaneous area near surgical wound

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.

Wound without local anesthesia

Nothing is injected into subcutaneous area near surgical wound

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine

Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No