UreterolithiasisNCT01412840
Sterile Water Injections for Relieving Ureterolithiasis Pain
A study testing Diclofenac and sterile water injections and Diclofenac and isotonic saline in people with Ureterolithiasis and Pain, run by University of Skövde at 1 site in Sweden.
Trial summary
Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ureterolithiasis, Pain
- What is being tested?
- Diclofenac and sterile water injections and Diclofenac and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ureterolithiasis pain, acute onset,
- Requires pain relief,
- Standard treatment prescribed,
- Age 18-60,
- Ability to understand and follow instructions
Who cannot join
- Other administration of NSAID for analgesia 12 hours prior to intervention,
- Pregnancy with obstructed flow of urine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial
Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. It would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.
- Conditions
- Ureterolithiasis, Pain
- Being tested
- Diclofenac and sterile water injections, Diclofenac and isotonic saline
- Keywords
- Ureterolithiasis, Pain, Complementary, RCT
- Medical subject headings
- Ureterolithiasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac and sterile water injectionsOther
The patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain.
Diclofenac and isotonic salineOther
The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain.
| Study group | Role | What they receive |
|---|---|---|
| Standard care and sterile water injections | Experimental | The patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain. Receives: Other: Diclofenac and sterile water injections |
| Standard care and isotonic saline | Placebo comparator | The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain. Receives: Other: Diclofenac and isotonic saline |
| Standard care | No intervention | The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in experience of pain
Measurement tool: Visual Analogue Scale (VAS)
Measured: VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment
Secondary outcomes (1)
Requirement for additional pain relief
The staff will reporter if any additional pain relief treatment have been used
Measured: Reported in the protocol up to two hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startJan 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreterolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Skövde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena B Martensson, University of Skövde
- Investigators
- Ingrid Bergh, PhD, Principal investigator, University of Skövde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412840
- Sponsor's protocol ID
- 787-08
- Status last verified
- Apr 2019
- First submitted
- 24 Nov 2010
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01412840
- Acronym / sponsor ID
- 787-08
- Conditions
- Ureterolithiasis, Pain
- Keywords
- Ureterolithiasis, Pain, Complementary, RCT
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SkövdeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. It would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care and sterile water injections | Experimental | Other: Diclofenac and sterile water injectionsThe patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain. |
| Standard care and isotonic saline | Placebo comparator | Other: Diclofenac and isotonic salineThe patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain. |
| Standard care | No intervention | –The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ureterolithiasis pain, acute onset,
- Requires pain relief,
- Standard treatment prescribed,
- Age 18-60,
- Ability to understand and follow instructions
Key exclusion criteria (2 listed)
- Other administration of NSAID for analgesia 12 hours prior to intervention,
- Pregnancy with obstructed flow of urine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac and sterile water injectionsThe patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain. | Other | Standard care and sterile water injections |
| Diclofenac and isotonic salineThe patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain. | Other | Standard care and isotonic saline |
Primary outcome
Change in experience of pain
Time frame: VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment
Measurement tool: Visual Analogue Scale (VAS)
1 secondary outcome
Requirement for additional pain relief
Time frame: Reported in the protocol up to two hours after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
Related trials for Ureterolithiasis
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Active, not recruiting
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney Calculi, Kidney Diseases
Recruiting
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
Urolithiasis, Kidney Calculi
RecruitingPhase 4
Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
Ureteral Calculi
Recruiting
UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Ureteral Stone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Bergh, PhD principal investigator
University of Skövde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac and sterile water injections and Diclofenac and isotonic saline in people with Ureterolithiasis and Pain, run by University of Skövde at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in experience of pain (time frame: VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.