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NCT03296189: LASTE

Local Anaesthetic and Steroid in the Ureter

Status unknown NA Last updated 17 January 2018
What this trial tests

NA trial testing Levobupivacaine in Pain, Postoperative in 150 participants. Status unknown.

Timeline
1 November 2018
Primary endpoint
1 December 2019
31 December 2019

Quick facts

Lead sponsorThe Adelaide and Meath Hospital, incorporating The National Children's Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment150
Start date1 November 2018
Primary completion1 December 2019
Estimated completion31 December 2019
Sites1 location across Ireland

Drugs / interventions tested

Conditions studied

Sponsor

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Who can join

18 and older, any sex, with Pain, Postoperative or Ureter Stone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Précis: Randomised control trial to evaluate safety and efficacy of intraluminal injection of high pH-high concentration of a long-acting local anesthetic and long-acting glucocorticoid in the ureter after ureteroscopy. Objectives: To evaluate a novel method to ameliorate post-ureteroscopy pain in all patients (with and without stents) Endpoints: Primary endpoint: mean visual analog pain scale (VAS) post-operatively starting at 1 hour, 4 hours, 8 hours, 24 hours and 7 days post-procedure (minimum of 3 VAS scores). VAS pain, ureteral stent symptoms and analgesic requirement will be assessed at different points during this time period. Secondary endpoint: Postoperative Nausea/Vomiting (PONV), safety of intraluminal injection of high concentration alkalinized local anaesthetic solution by comparing adverse events between placebo and treatment arms. In addition, rehospitalisation rates and postoperative length of stay will be compared between the three groups. Population: 150 adult patients undergoing ureteroscopy for ureteric stone disease stratified into negative ureteroscopy and those treated for a stone with or without stent insertion postoperatively Number of Sites: Tallaght Hospital Study Duration: 8 months

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Levobupivacaine

Trials testing the same drug.

Other recruiting trials for Pain, Postoperative

Currently open trials in the same condition.

Other The Adelaide and Meath Hospital, incorporating The National Children's Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03296189.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing