Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia, Opioid Use During Medical Care
Conditions
Keywords
renal colic, kidney stones, lidocaine, opioid use
Brief summary
The opioid epidemic continues to be a major public health crisis in the United States. According to the Center for Disease Control, approximately 8 million Americans reported misusing prescription opioids in 2023, with over 5 million Americans reporting that they suffer from opioid use disorder. The United States government estimates that 105,000 people died from drug overdose in 2023, and approximately 80,000 of those deaths can be attributed to opioids (\ 76%). In acknowledgement of the opioid crisis, we wish to contribute to ongoing efforts to reduce unnecessary and excessive opioid prescription. In 2012, researchers in Iran published a randomized controlled trial comparing intravenous (IV) lidocaine to IV morphine for acute renal colic, reporting that 90% patients responded "successfully" in the lidocaine group versus 70% in the morphine group. They also concluded that there was a statistically significant difference between pain scores between the two groups at all time points, favoring the lidocaine group. However, the study was conducted at a single emergency department in Tabriz, Iran, with a relatively homogenous patient population, and the researchers did not explicitly define their primary outcome variable for what constituted a "successful" response in the treatment groups. The investigators of this study aim to build upon this preliminary evidence by recruiting a more diverse population to improve generalizability and by predefining pain-reduction thresholds to allow for more meaningful comparison between the interventions.
Detailed description
Purpose ● To determine whether IV lidocaine is more efficacious than IV morphine in decreasing or resolving acute renal colic pain refractory to initial treatment with parenteral ketorolac Primary Objective ● To compare the efficacy of IV lidocaine versus IV morphine in achieving at least 50% reduction of pain score at 30 minutes for renal colic requiring rescue medication after initial treatment with parenteral ketorolac Secondary Objectives * To compare reduction in pain scores at 15, 60, and 90 minutes between the two intervention groups; * To determine if there is a statistically significant difference in emergency department length of stay (ED LOS) between the two intervention groups * To determine if there is a statistically significant difference in need for further rescue medications between the two intervention groups * To determine the incidence of adverse effects between the two intervention groups * To evaluate whether there is a correlation between age and efficacy of treatment between the two intervention groups Study Design This study is a prospective randomized controlled trial. Study participants will be randomized to receive either IV lidocaine or IV morphine if they fail initial standard treatment with parenteral ketorolac for suspected acute renal colic. Study Date Range and Duration The estimated study period will be from 1/1/2026 to 12/31/2027. The study will be carried out for two calendar years, and may be halted early when sufficient participant enrollment has occurred. Number of Study Sites 1. Loma Linda University Medical Center - Adult Emergency Department (Adult ED) 2. Loma Linda University Medical Center - East Campus Advanced Urgent Care (AUC) Primary Outcome Variables ● Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 30 minutes Secondary and Exploratory Outcome Variables * Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes * Adverse events attributed to IV lidocaine or IV morphine * ED LOS * Need for additional rescue medications after either IV lidocaine or IV morphine Study Population Study participants will be enrolled from patients who have suspected renal colic as determined by the treating clinician at the Loma Linda Adult ED or AUC. Number of Participants This study seeks to enroll at least 248 patients over the study period, with at least 190 patients required to achieve a standard statistical power of 80%. Patients will be randomized into two groups - 124 patients per group. Study Schedule All data and information, including consent and screening, will be gathered during the course of a patient's single visit at the Loma Linda Adult ED or AUC.
Interventions
DRUGLidocaine
We hypothesize that IV lidocaine outperforms IV morphine at 30 minutes in achieving ≥ 50% reduction in pain score for renal colic that is refractory to initial treatment with parenteral ketorolac.
We hypothesize that IV lidocaine outperforms IV morphine at 30 minutes in achieving ≥ 50% reduction in pain score for renal colic that is refractory to initial treatment with parenteral ketorolac.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible for inclusion in the study, an individual must meet all of the following criteria: * Age ≥ 18 years at time of visit * Able and willing to consent for participation in study * Documentation of suspected renal colic as primary complaint as evidenced by reported flank pain, back pain, abdominal pain, or groin pain, or as determined by the treating clinician * Requires additional treatment due to inadequate analgesia or clinical suspicion of unsafe discharge secondary to pain after initial treatment with parenteral ketorolac
Exclusion criteria
Any individual who meets any of the following criteria will be excluded from participation in this study: * Age \< 18 years * Use of analgesia for renal colic within 6 hours prior to clinician evaluation * Inability or unwillingness to consent for participation in study * Experienced a severe adverse event that required clinician intervention after initial treatment with parenteral ketorolac * Documented history of allergic or anaphylactic reaction to NSAIDs, lidocaine, or morphine * Documented history of cardiac arrhythmias * Documented history of chronic use of opioid medications for unrelated diagnoses * Currently pregnant * Documented history of end-stage renal or hepatic dysfunction * Clinical contraindications to NSAIDs, lidocaine, or morphine per clinician discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to treatment | 30 minutes after completion of medication administration | Pain assessment using a numeric rating scale (0 to 10) at 30 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response to treatment | 15, 60, 90 minutes after completion of medication administration | Pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes |
| Adverse events | From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours | Adverse events attributed to IV lidocaine or IV morphine |
| Emergency Department Length of Stay | From time of patient registration in the emergency department to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours | — |
| Rescue medications | From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours | Need for additional rescue medications after either IV lidocaine or IV morphine |
Contacts
CONTACTSarah Aly, DO, MSc
Outcome results
None listed