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NCT02444260
Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation
Phase 3 trial testing Midazolam in Inguinal Hernia in 180 participants. Status unknown.
1 December 2015
Quick facts
| Lead sponsor | The University of The West Indies |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 1 December 2013 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across Jamaica |
Drugs / interventions tested
- Midazolam (midazolam) — full drug profile →
- Intravenous Normal Saline — full drug profile →
- Bupivocaine — full drug profile →
- Lignocaine HCl
Conditions studied
- Inguinal Hernia — all drugs for Inguinal Hernia →
- Anesthesia, Local — all drugs for Anesthesia, Local →
- Conscious Sedation — all drugs for Conscious Sedation →
Sponsor
The University of The West Indies
Who can join
Adults 18 to 75, any sex, with Inguinal Hernia or Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
Time frame: 1 year
Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.
Leake PA, Toppin PJ, Reid M, Plummer JM, et al · · 2017 · cited 2× · PMID 28174148 · DOI 10.2196/resprot.6754
Verify or expand the search:
- PubMed search for NCT02444260
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Inguinal Hernia
Currently open trials in the same condition.
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Other The University of The West Indies trials
Trials by the same sponsor.
- NCT07177001 — Neck and Low Back Pain in Physical Therapy Students at The University of the West Indies, Mona, Jamaica · NA · not yet recruiting
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- NCT07194746 — The Prevalence of Neck and Low Back Pain in FMSTRC Staff At the UWI Mona · NA · not yet recruiting
- NCT05856968 — Investigation of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection · NA · not yet recruiting
- NCT05730244 — A Study of the Clinical Efficacy and Safety of 20% Cassia Alata Extract Against Tinea Versicolor · Phase 1 · 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 NCT02444260 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of The West Indies
- Last refreshed: 13 May 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02444260.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing