Status:
UNKNOWN
Laparoscopic Transversus Abdominis Plane Block (LTAP) for Appendicectomy Versus Standard Port Site Treatment
Lead Sponsor:
Royal College of Surgeons, Ireland
Conditions:
Pain
Appendicitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to compare Laparoscopic assisted LTAP (Transversus Abdominis Plane) to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3, 6, 12 and ...
Detailed Description
Title: Randomised Controlled Trial to compare Laparoscopic Transversus Abdominis Plane Block (LTAP) for appendicectomy versus standard treatment Short title: (TAP Block Study) Laparoscopic Transversus...
Eligibility Criteria
Inclusion
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for follow up telephone follow up
- Male or female, aged over 18
- Diagnosed either clinically or radiologically (CT/US/MRI) with appendicitis
- Uncomplicated or complicated appendicitis
- Undergoing laparoscopic appendicitis surgery only
- Must be fluent in English in order to complete telephone follow up questionnaire
- Fulfillment of each criteria must be clearly evidenced (in lab reports or correspondence) and/or documented in the medical records.
Exclusion
- Male or female under the age or 18
- Laparoscopic converted to open appendicectomy (during surgical procedure)
- Open appendicectomy (planned)
- Pregnancy.
- Females must not be breastfeeding
- Known allergic reactions to components of the study product(s) )
- Not fluent in English - which would prevent participants to complete follow up telephone questionnaire
- Malignant appendicitis
- Spinal Anaesthesia, Epidural analgesia catheter or injections, Post-operative requirements for patient controlled analgesia (PCA)
- Right hemicolectomy or any concomitant or simultaneous intervention
- Allergy or hypersensitivity to any of the components of Bupivacaine
- Presence of any other illness or condition that renders the patient unsuitable for trial participation in the opinion of the investigator
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05427266
Start Date
July 1 2022
End Date
December 1 2023
Last Update
June 28 2022
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