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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03481517
Enrollment
47
Registered
2018-03-29
Start date
2018-04-23
Completion date
2019-07-31
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis Acute

Keywords

adult, appendectomy, appendicitis, local anesthesia, pain

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.

Interventions

DRUGBupivacaine

Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Pain score of surgical wound of the patientwithin 24 hours after surgeryUsing 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

Secondary

MeasureTime frameDescription
Satisfaction of the patientup to one month after surgeryUsing questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026