Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 4:27 AM
Study NCT ID:
NCT02444260
Status:
UNKNOWN
Last Update Posted:
2015-05-14
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
Sponsor:
The University of The West Indies
Organization:
Study Overview
Official Title:
Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation
Specific study objectives are to determine the effect of conscious sedation on:
(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications
Specific study objectives are to determine the effect of conscious sedation on:
(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: