Optimization of pain management for acute renal colic in the Emergency Department – The OPTIMIZED trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

20 Apr 2026 → ongoing

Decision date (initial)

2025-11-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMw

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of this trial is to investigate the efficacy of an Erector Spinae Plane Block (ESPB) in managing pain for acute renal colic in the ED. This study hypothesizes that ESPB is an effective adjunct to control pain in patients with renal colic, that it increases patient satisfaction, and reduces healthcare costs by minimizing hospitalizations and interventions.

Conditions and MedDRA coding

Urolithiasis

Regulatory references

Scientific advice from competent authorities

Leids Universitair Medisch Centrum (LUMC)

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age 18 years or older
2. Able and willing to provide informed consent
3. 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
4. Persistent pain (NRS ≥ 4) after radiologic confirmation of urolithiasis and initial pain medication

Exclusion criteria 12

1. Pregnant or lactating patients
2. Weight <37kg
3. Inability to complete online questionnaires in Dutch, send via email
4. Known allergy to local anaesthetics from the amide-type such as ropivacaine or bupivacaine
5. 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]
6. Patients presenting with urosepsis or fever
7. Patients with a solitary kidney
8. Patients with a blow-out of the renal collecting system
9. Patients with a skin infection at the puncture site of the ESPB
10. Bilateral ureter obstruction
11. Anuric patients
12. Patients using class III anti-arrhythmic drugs (amiodaron, ibutilide)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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).

Secondary endpoints 10

1. 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).
2. Representations to the ED related to renal colic within seven days after the inter-vention, compared between both groups.
3. 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
4. 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.
5. Patient satisfaction, measured by Patient Global Impression of Change (PGIC) after 24 hours and seven days, compared between both groups
6. Reduction of use of analgesic rescue medication within the first 24 hours after the intervention, compared between both groups.
7. Time to first analgesic rescue medication (both NSAIDs and opioids) after the inter-vention, compared between both groups.
8. Reduction of opioid-related adverse events, measured by the Overall Benefit of Analgesia Score after 24 hours.
9. 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.
10. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Anouk Top

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Anouk Top

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications