A Phase 4 interventional study of Bupivacaine in Appendicitis Acute, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's enrollment of 47 is below the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Including criteria:
Exclusion criteria:
5 mL Bupivacaine is injected into subcutaneous area near surgical wound
Drug: Bupivacaine
Nothing is injected into subcutaneous area near surgical wound
Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.
Also known as: Marcaine
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
Time frame: within 24 hours after surgery
Satisfaction of the patient
Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.
Time frame: up to one month after surgery
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
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