AnalgesiaPhase 4NCT03032458
Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy
A Phase 4 study testing Pethidine, Ketorolac and Xylocaine Gel in people with Analgesia and Urolithiasis, run by Mansoura University at 1 site in Egypt.
Trial summary
A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Analgesia, Urolithiasis
- What is being tested?
- Pethidine, Ketorolac and Xylocaine Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Oct 2017
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with renal and upper ureteral stones amenable to SWL.
Who cannot join
- Allergy to pethidine.
- Allergy to Ketorolac.
- Allergy to Xylocaine gel.
- American Society of Anesthesiologists score ≥ 3 (ASA III or more).
- Pregnancy.
- Patients with a pacemaker.
Show all 12Show fewer
- Bleeding diatheses.
- Uncontrolled urinary tract infection (UTI).
- Severe obesity which prevent targeting of the stone.
- Body Mass IndexBMI (40 or more)
- Arterial aneurysm in the vicinity of the stone.
- Anatomical obstruction distal to the stone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial
A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.
Read the detailed description
Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL.
Several physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin.
Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation.
Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice.
In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode.
The investigators will try in this trial to identify the best efficacious type of analgesia for patient during SWL in this study.
- Conditions
- Analgesia, Urolithiasis
- Being tested
- Pethidine, Ketorolac, Xylocaine Gel
- Keywords
- Shock Wave Lithotripsy, Ketorolac, Xylocaine Gel, Pethidine
- Medical subject headings
- Agnosia, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PethidineDrug
Also called Pethidine 50
pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg
KetorolacDrug
Also called Ketolac
ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.
Xylocaine GelDrug
Also called lidocaine 2%
Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
| Study group | Role | What they receive |
|---|---|---|
| Pethidine | Active comparator | Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt) Receives: Drug: Pethidine |
| Ketorolac | Active comparator | Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt) Receives: Drug: Ketorolac |
| Xylocaine Gel | Active comparator | Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt) Receives: Drug: Xylocaine Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"
Measured: 10 months
Secondary outcomes (3)
Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "
Measured: 10 months
Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"
Measured: 10 months
Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Hassan Abol-Enein, MD, Phd, Study chair, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032458
- Sponsor's protocol ID
- MD/16.11.72
- Status last verified
- May 2018
- First submitted
- 10 Jan 2017
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03032458
- Acronym / sponsor ID
- MD/16.11.72
- Conditions
- Analgesia, Urolithiasis
- Keywords
- Shock Wave Lithotripsy, Ketorolac, Xylocaine Gel, Pethidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Jan 2017 (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.
A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.
Detailed description
Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL.
Several physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin.
Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation.
Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice.
In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode.
The investigators will try in this trial to identify the best efficacious type of analgesia for patient during SWL in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pethidine | Active comparator | Drug: PethidinePethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt) |
| Ketorolac | Active comparator | Drug: KetorolacKetolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt) |
| Xylocaine Gel | Active comparator | Drug: Xylocaine GelXylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with renal and upper ureteral stones amenable to SWL.
Key exclusion criteria (12 listed)
- Allergy to pethidine.
- Allergy to Ketorolac.
- Allergy to Xylocaine gel.
- American Society of Anesthesiologists score ≥ 3 (ASA III or more).
- Pregnancy.
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 |
|---|---|---|
| PethidineAlso: Pethidine 50pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg | Drug | Pethidine |
| KetorolacAlso: Ketolacketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg. | Drug | Ketorolac |
| Xylocaine GelAlso: lidocaine 2%Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then | Drug | Xylocaine Gel |
Primary outcome
Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"
Time frame: 10 months
3 secondary outcomes
Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "
Time frame: 10 months
Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"
Time frame: 10 months
Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)
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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.
Hassan Abol-Enein, MD, Phd study chair
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pethidine, Ketorolac and Xylocaine Gel in people with Analgesia and Urolithiasis, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 29 May 2018. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)" (time frame: 10 months). 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 29 May 2018.