Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

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

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis Acute
• Intervention / Treatment: Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chih-Yang Hsiao, M.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pain; adult; appendicitis; local anesthesia; appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 201710064RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No