ROPIVACAINE HYDROCHLORIDE for Urolithiasis

Inclusion criteria

• {"criterion_text":"- Age 18 years or older"}
• {"criterion_text":"- Able and willing to provide informed consent"}
• {"criterion_text":"- Confirmed urolithiasis by ultrasound (performed by radiologic expert, stone must be seen, not only secondary characteristics such as hydronephrosis) or CT-scan during ED visit"}
• {"criterion_text":"- Persistent pain (NRS ≥ 4) after radiologic confirmation of urolithiasis and initial pain medication"}

Exclusion criteria

• {"criterion_text":"- Pregnant or lactating patients"}
• {"criterion_text":"- Bilateral ureter obstruction"}
• {"criterion_text":"- Anuric patients"}
• {"criterion_text":"- Patients using class III anti-arrhythmic drugs (amiodaron, ibutilide)"}
• {"criterion_text":"- Weight <37kg"}
• {"criterion_text":"- Inability to complete online questionnaires in Dutch, send via email"}
• {"criterion_text":"- Known allergy to local anaesthetics from the amide-type such as ropivacaine or bupivacaine"}
• {"criterion_text":"- Use of vitamin K antagonist with INR ≥4.5 or clotting disorders (conform guideline other nerve blocks NVSHA) [NB the use DOAC’s or thrombocyte aggregation inhibitors is not a contra-indication]"}
• {"criterion_text":"- Patients presenting with urosepsis or fever"}
• {"criterion_text":"- Patients with a solitary kidney"}
• {"criterion_text":"- Patients with a blow-out of the renal collecting system"}
• {"criterion_text":"- Patients with a skin infection at the puncture site of the ESPB"}

Primary endpoints

• {"endpoint_text":"- To decrease pain intensity and pain interference, as measured with the Brief Pain Inventory Short Fort (BPI-SF). This is defined as the difference in scores 24 hours after the intervention between the two groups.","definition_or_measurement_approach":"Measured with the Brief Pain Inventory Short Form (BPI-SF); defined as the difference in BPI-SF scores 24 hours after the intervention between the two groups."}
• {"endpoint_text":"- To minimize hospitalizations and urologic interventions. This is defined as the difference in proportion of patients that required a same-day hospital admission or underwent a urologic intervention within seven days (yes/no).","definition_or_measurement_approach":"Defined as difference in proportion of patients requiring same-day hospital admission or undergoing a urologic intervention within seven days (binary yes/no outcome) between groups."}

Secondary endpoints

• {"endpoint_text":"- A decrease in pain intensity as measured with the Numeric Rating Scale (NRS) be-tween baseline and 30 minutes, 60 minutes, six hours, twelve hours and 24 hours after the intervention (but only measured during the time the patient is awake).","definition_or_measurement_approach":"NRS measured at baseline, 30 min, 60 min, 6 h, 12 h and 24 h; comparisons between groups over these timepoints."}
• {"endpoint_text":"- Representations to the ED related to renal colic within seven days after the inter-vention, compared between both groups.","definition_or_measurement_approach":"Occurrence of ED re-presentation related to renal colic within 7 days post-intervention; compare proportions between groups."}
• {"endpoint_text":"- Incidence of chronic pain, measured by the BPI-SF one month after the interven-tion. The definition of chronic secondary pain this study uses is “Pain that persists or recurs beyond successful treatment of the initial cause","definition_or_measurement_approach":"Incidence of chronic pain at 1 month measured by BPI-SF; chronic pain defined as pain that persists or recurs beyond successful treatment of the initial cause."}
• {"endpoint_text":"- Improvement of quality of life, measured by the EQ-5D-5L seven days and one month after the intervention, compared to baseline in both groups.","definition_or_measurement_approach":"EQ-5D-5L measured at 7 days and 1 month versus baseline; compare changes between groups."}
• {"endpoint_text":"- Patient satisfaction, measured by Patient Global Impression of Change (PGIC) after 24 hours and seven days, compared between both groups","definition_or_measurement_approach":"PGIC measured at 24 hours and 7 days; compare scores/proportions between groups."}
• {"endpoint_text":"- Reduction of use of analgesic rescue medication within the first 24 hours after the intervention, compared between both groups.","definition_or_measurement_approach":"Use of rescue analgesia within first 24 hours; compare rates/amounts between groups."}
• {"endpoint_text":"- Time to first analgesic rescue medication (both NSAIDs and opioids) after the inter-vention, compared between both groups.","definition_or_measurement_approach":"Time (time-to-event) until first rescue analgesic (NSAID or opioid); compare between groups."}
• {"endpoint_text":"- Reduction of opioid-related adverse events, measured by the Overall Benefit of Analgesia Score after 24 hours.","definition_or_measurement_approach":"Overall Benefit of Analgesia Score (OBAS) at 24 hours; compare between groups to assess opioid-related adverse events."}
• {"endpoint_text":"- Safety, measured as the number and type of serious adverse events (such as infection, bleeding, LAST or pneumothorax) related to the ESPB occurring within one month of the intervention.","definition_or_measurement_approach":"Count and type of serious adverse events related to ESPB occurring within 1 month (e.g., infection, bleeding, LAST, pneumothorax)."}
• {"endpoint_text":"- Cost-effectiveness: relating the costs of healthcare use and productivity losses related to the renal colic, measures via shortened versions of the iMTA Medical Consumption Ques-tionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ), up to one month after intervention to the quality of life","definition_or_measurement_approach":"Cost-effectiveness analysis using shortened iMCQ and iPCQ up to 1 month post-intervention related to quality of life (EQ-5D-5L)."}

Netherlands

Earliest CTIS Part Ii Submission Date

13-11-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

34

Number Of Sites

8

Number Of Participants

160

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands