Renal StoneNCT04160936
The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy
A study testing Marcaine Injectable Product in people with Renal Stone, run by Saddam Al Demour at 1 site in Jordan.
Trial summary
The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Stone
- What is being tested?
- Marcaine Injectable Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 10 Feb 2018to 12 Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age
- body mass index <35,
- renal stone size >2.0 cm.
Who cannot join
- patients having supra-costal puncture.
- excessive intraoperative bleeding.
- renal stones requiring more than a single puncture.
- surgical procedure extending more than 3 hours.
- urinary tract infection.
- severe cardiopulmonary disease.
- abnormal renal function tests.
- allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy
The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.
Read the detailed description
The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.
- Conditions
- Renal Stone
- Being tested
- Marcaine Injectable Product
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine Injectable ProductDrug
Also called Sensorcaine Injectable Product
Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration
| Study group | Role | What they receive |
|---|---|---|
| study group :infiltration with 0.25% bupivacaine post-op | Active comparator | At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin Receives: Drug: Marcaine Injectable Product |
| control group , no anesthesia infiltration post-op | No intervention | control group: no anesthesia infiltration had been given post opertatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS )
Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours
Measured: 1, 4, 8, 12, 24, and 48 hours
Dynamic Visual Analogue Scale (DVAS)
Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours
Measured: 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours
Secondary outcomes (3)
The time for the first opioid demand
first post op time for analgesia
Measured: 48 hours
the number of opioid demands
total number of opioid given to the patient
Measured: 48 hours
total opioid consumption
total amount of opioid consumption
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start10 Feb 2018
- Primary completion12 Sep 2020
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saddam Al Demour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Saddam Al Demour, University of Jordan
- Investigators
- Saddam AlDemour, professor, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160936
- Sponsor's protocol ID
- Sad2007
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD sharing plan
Publications
Al Demour SH, Halalsheh OM, Al-Azab RS, Al-Zubi MT, Al-Rawashdah SF, Ibrahim MM, Abubaker AK, Aloweidi AS, Almustafa MM. The efficacy of bupivacaine infiltration along nephrostomy tract on postoperative pain control and opioid consumption after PCNL: a prospective randomized controlled trial. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4951-4959. doi: 10.26355/eurrev_202306_32612.
PubMed 37318469
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04160936
- Acronym / sponsor ID
- Sad2007
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saddam Al DemourUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- 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.
The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.
Detailed description
The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group :infiltration with 0.25% bupivacaine post-op | Active comparator | Drug: Marcaine Injectable ProductAt the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin |
| control group , no anesthesia infiltration post-op | No intervention | –control group: no anesthesia infiltration had been given post opertatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years of age
- body mass index <35,
- renal stone size >2.0 cm.
Key exclusion criteria (8 listed)
- patients having supra-costal puncture.
- excessive intraoperative bleeding.
- renal stones requiring more than a single puncture.
- surgical procedure extending more than 3 hours.
- urinary tract infection.
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 |
|---|---|---|
| Marcaine Injectable ProductAlso: Sensorcaine Injectable ProductFollowing PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration | Drug | study group :infiltration with 0.25% bupivacaine post-op |
Primary outcome
visual analogue scale (VAS )
Time frame: 1, 4, 8, 12, 24, and 48 hours
Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours
Dynamic Visual Analogue Scale (DVAS)
Time frame: 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours
Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours
3 secondary outcomes
The time for the first opioid demand
Time frame: 48 hours
the number of opioid demands
Time frame: 48 hours
total opioid consumption
Time frame: 48 hours
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 14 Nov 2022.
- Derived from this study: PubMed 37318469Al Demour SH, Halalsheh OM, Al-Azab RS, Al-Zubi MT, Al-Rawashdah SF, Ibrahim MM, Abubaker AK, Aloweidi AS, Almustafa MM. The efficacy of bupivacaine infiltration along nephrostomy tract on postoperative pain control and opioid consumption after PCNL: a prospective randomized controlled trial. Eur Rev Med Pharmacol Sci. 2023 Jun;27(11):4951-4959. doi: 10.26355/eurrev_202306_32612.
- Individual participant dataSharing planned: No. no IPD sharing plan
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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.
Saddam AlDemour, professor principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marcaine Injectable Product in people with Renal Stone, run by Saddam Al Demour at 1 site in Jordan.
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 3 inclusion and 8 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 14 Nov 2022. 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 Jordan. 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.
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?
visual analogue scale (VAS ) (time frame: 1, 4, 8, 12, 24, and 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160936, which also lists 1 linked publication.
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 14 Nov 2022.