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NCT03481517
Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult
Phase 4 trial testing Bupivacaine in Appendicitis Acute in 47 participants. Completed in 31 July 2019.
8 July 2019
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 23 April 2018 |
| Primary completion | 8 July 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Bupivacaine (BUPIVACAINE) — full drug profile →
Conditions studied
- Appendicitis Acute — all drugs for Appendicitis Acute →
Sponsor
National Taiwan University Hospital
Who can join
20 and older, any sex, with Appendicitis Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03481517
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Related trials
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Trials testing the same drug.
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- NCT07465185 — Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery · Phase 2 · recruiting
- NCT07430085 — Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA · Phase 4 · not yet recruiting
- NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
Other recruiting trials for Appendicitis Acute
Currently open trials in the same condition.
- NCT07521969 — Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial. · NA · recruiting
- NCT06815822 — Prevention of Postoperative Hernias in Emergency Surgery · recruiting
- NCT06948071 — Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis · NA · recruiting
- NCT06762275 — The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care · NA · recruiting
- NCT06395636 — Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients · NA · recruiting
Other National Taiwan University Hospital trials
Trials by the same sponsor.
- NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
- NCT05396222 — A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar · NA · not yet recruiting
- NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
- NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
- NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03481517 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 27 April 2020
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