Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

NCT03481517 | Completed Phase 4

• 1 other identifier: 201710064RINB
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute

Keywords

adult; appendectomy; appendicitis; local anesthesia; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction of the patient

  up to one month after surgery

Study Arms (2)

Wound with local anesthesia

EXPERIMENTAL

5 mL Bupivacaine is injected into subcutaneous area near surgical wound

Drug: Bupivacaine

Wound without local anesthesia

NO INTERVENTION

Nothing is injected into subcutaneous area near surgical wound

Interventions

Bupivacaine DRUG

Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.

Also known as: Marcaine

Wound with local anesthesia

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Appendicitis; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Chih-Yang Hsiao, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 29, 2018
• Study Start: April 23, 2018
• Primary Completion: July 8, 2019
• Study Completion: July 31, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

TW (1)