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Local Anaesthetic and Steroid in the Ureter

NCT03296189 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-01-17

No results posted yet for this study

Summary

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

Conditions

  • Pain, Postoperative
  • Ureter Stone

Interventions

DRUG

Levobupivacaine

intraluminal injection post procedure for pain relief: alkalinised high concentration 10 mls

DRUG

Dexamethasone Sodium Phosphate

intraluminal injection post procedure for pain relief: alkalinised high concentration 10 mls levobupivicaine and 2mls dexamethasone

DRUG

Placebos

10 mls normal saline

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-12-01
Completion
2019-12-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296189 on ClinicalTrials.gov