Kidney StoneNCT04835922
Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL
A study testing Intercostal Nerve Block and Peritract Infiltration in people with Kidney Stone, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
Percutaneous nephrolithotomy (PCNL) is the preferred treatment for renal stones >2 cm or resistant to ESWL. Postoperative pain following this invasive surgery adds to the morbidity of patient which requires additional analgesia and can affect the quality of care. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Intercostal Nerve Block and Peritract Infiltration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 9 Nov 2020to 12 Nov 2021
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital.
Who cannot join
- Patient ≤16 years of age, known history of hypersensitivity/anaphylaxis/ contraindications to bupivacaine, Systemic Diseases (CKD, active UTI, untreated sepsis), Relook surgery, high ASA grade ( >2) unfit for anesthesia/PCNL , Contraindications for PCNL (pregnancy, coagulopathy) , Patients who decline to participate
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
Tribhvan University Teaching Hospital
Kathmandu, Bagmati, 00977
Sushil Gyawali, MS Resident, +9779849742715, drsushilgyawali@gmail.com
Bhojraj Luitel, MCh Urology, +9779851222344, drbhojraj@gmail.com
About this study
Official title: Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial
Percutaneous nephrolithotomy (PCNL) is the preferred treatment for renal stones >2 cm or resistant to ESWL. Postoperative pain following this invasive surgery adds to the morbidity of patient which requires additional analgesia and can affect the quality of care. To lower the morbidity of PCNL, proper and adequate management of postoperative pain remains an integral component of PCNL.
There are many ways to reduce the postoperative pain following PCNL including mini PCNL, tubeless PCNL, use of regional analgesia etc. However the modality of analgesic technique is still a matter of debate. The aim of this study is to evaluate the efficacy of intercostal nerve block compared with peritract infiltration in patient undergoing PCNL. Specifically, the study will look on to the demography of patients undergoing PCNL and their indications. The study will also compare the intensity of pain in two groups using visual analogue scale (VAS). The study will be a prospective double blinded randomized clinical trial done at Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching hospital (TUTH). The time frame of this study will be of 1 year or when sample size is fulfilled including all the patients who visit the hospital for PCNL and fulfils the inclusion criteria. At the end of our study we expect to conclude that the use of intercostal nerve block is superior or inferior than or equal to peritract infiltration in alleviating the postoperative pain following PCNL.
Read the detailed description
Introduction:
The incidence and prevalence of renal calculi have increased globally across all ages, sex, and race, probably due to change in dietary habits and global warming. PCNL is considered 'gold standard' for the management of large renal calculi because it is less invasive and morbid than the open surgery. Currently, the indications for PCNL include large size renal calculi (>1.5-2 cm), staghorn calculi, upper tract calculi not responding to other modalities of treatment, lower pole stones, cystine nephrolithiasis, and stones in anatomically abnormal kidneys. However, the procedure causes postoperative pain, mostly due to dilatation of the renal capsule, the parenchyma and pain along the tract of the nephrostomy tube. So the postoperative pain remains an integral part of management. Postoperative pain management not only reduces patient suffering but also improve patient satisfaction, reduces morbidity and in parallel enhances recovery, improves rehabilitation, reduces hospital stay and thereby overall hospital cost. The postoperative pain due to the procedure may vary with individual pain perception, use of percutaneous nephrostomy (PCN) tubes, comorbid conditions, choice of analgesic route, anesthetic agents and postoperative course. Small calibers of tubes, even mini PCNL or tubeless PCNL and regional analgesia such as intercostal nerve block, peritract infiltration, paravertebral block etc. could further decrease postoperative pain and analgesic requirement and hence improving postoperative patient comfort. However, studies on these techniques have produced conflicting results due to the use of different local anesthetics, various regional techniques, and different study designs. So this study aims to compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in alleviating postoperative pain following the procedure with the subjective assessment of pain
Rational/justification :
- The optimal method of pain control after percutaneous nephrolithotomy remains controversial till now.
We need better technique of analgesia to decrease the pain following PCNL.
- Intercostal nerve block and peritract infiltration are common regional analgesic methods used by most of the investigators that had shown to be adequate for postoperative pain control.
- This study may be helpful in providing evidence for a clinical guideline to manage postoperative pain that will eventually help to decrease the morbidity and bring better outcome.
General Objective :
To compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy.
Specific Objective :
- To analyse the demography of the patient [age, sex, BMI, stone size and laterality, renal function test, stone burden (size, Guy's Stone score etc.)] undergoing PCNL.
- To compare the intensity of pain using visual analogue score, resting and dynamic VAS scores, following PCNL between two groups (ICNB and PTI).
- To compare the time to first rescue analgesia and total analgesic requirement between both groups.
- To document the complications of both groups.
Research Hypothesis Is Intercostal nerve block more efficacious than peritract infiltration following PCNL in alleviating pain?
Study Variables
- Independent Variables: Age, Sex, BMI, stone location, laterality and size, Guys Stone score (burden), ASA grade, comorbidity, Group I (ICBN), Group P (PTI) nephrostomy tract size (mini vs standard), no of Tracts (single vs multiple), use to tube (tube vs tubeless), length of hospital stay, stone clearance, complications
- Dependent Variables R-VAS score, D-VAS score, Time to first analgesic demand, Total analgesic requirement
- Conditions
- Kidney Stone
- Being tested
- Intercostal Nerve Block, Peritract Infiltration
- Keywords
- PCNL, Intercostal nerve block, Peritract Infiltration, Bupivacaine, Kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal Nerve BlockProcedure or surgery
Also called Regional anesthesia
: Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each)
Peritract InfiltrationProcedure or surgery
Also called Regional anesthesia
At the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position).
| Study group | Role | What they receive |
|---|---|---|
| Intercostal Nerve Block | Experimental | • In Group I (ICBN group): Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine at the termination of PCNL under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each). Receives: Procedure: Intercostal Nerve Block |
| Peritract infiltration | Active comparator | In Group P (PTI): Single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given on completion of PCNL by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Then the surgical wound and intervention site will be covered with an occlusive dressing. Receives: Procedure: Peritract Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS score)
Patients undergoing PCNL who fulfil the inclusion criteria will be identified at the time of admission. • Patients will be randomized in two groups using sealed envelope method into ICNB (group I) and PTI (group P) prior to surgery. After the procedure (intervention) the intensity of pain will be evaluated by an independent observer (the researcher or an independent ward nurse) blinded to the allocated groups at postoperative 2, 8, 12 and 24 hours. The pain score will be assessed separately by Visual Analogue Scale (VAS), a 10-point scale ranging from 0, minimum or no pain, to 10, the maximum pain score perceived or imagined by the patient, at rest (RVAS) and on deep breathing or coughing known as dynamic VAS (DVAS). •
Measured: up to 24 hours
Secondary outcomes (2)
Time to First Rescue analgesia
Pain score will be recorded after the intervention as described earlier. Patients who will have VAS score of > 4 or intractable pain will be given rescue analgesia, that is injection ketorolac intravenously. The usual dose is 30 mg 4-6 hourly by the intravenous route. The time after procedure that patient needs first dose of rescue analgesia i.e Inj Ketorolac will be recorded. Dosage will be adjusted according to pain severity and response.
Measured: up to 24 hours
Total Analgesic Requiremennt
Total Analgesia requirement of Inj Ketorolac required by the patient for the first 24 hours up to the discharge will be added up and recorded along with the time given.
Measured: up to 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start9 Nov 2020
- Primary completion9 Nov 2021 (estimated)
- Study completion12 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the study will be prospective double blind randomized trial using 0.25% bupivacaine in patients undergoing PCNL under one of the two arms: Intercostal Nerve block or Peritract Infiltration.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sushil Gyawali, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Investigators
- Uttam Sharma, MS Surgery, Study chair, HOD, Department of Urology and Kidney Transplant Surgery, TUTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835922
- Sponsor's protocol ID
- 615-2020
- Other IDs
- REF/2021/01/000059
- Status last verified
- Apr 2021
- First submitted
- 20 Feb 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is completed, results will be published as Original Article in Journal. Relevant Individual data will be published in Journal itself as a part of the article.
Publications
Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. Indian J Anaesth. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA_88_17.
PubMed 28890561Singh I, Yadav OK, Gupta S. Efficacy of intercostal nerve block with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Urol Ann. 2019 Oct-Dec;11(4):363-368. doi: 10.4103/UA.UA_141_18.
PubMed 31649454Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27.
PubMed 29288788
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in Percutaneous Nephrolithotomy: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04835922
- Acronym / sponsor ID
- 615-2020
- Conditions
- Kidney Stone
- Keywords
- PCNL, Intercostal nerve block, Peritract Infiltration, Bupivacaine, Kidney stone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Nov 2021 (estimated)
- Study completion
- 12 Nov 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
Percutaneous nephrolithotomy (PCNL) is the preferred treatment for renal stones >2 cm or resistant to ESWL. Postoperative pain following this invasive surgery adds to the morbidity of patient which requires additional analgesia and can affect the quality of care. To lower the morbidity of PCNL, proper and adequate management of postoperative pain remains an integral component of PCNL.
There are many ways to reduce the postoperative pain following PCNL including mini PCNL, tubeless PCNL, use of regional analgesia etc. However the modality of analgesic technique is still a matter of debate. The aim of this study is to evaluate the efficacy of intercostal nerve block compared with peritract infiltration in patient undergoing PCNL. Specifically, the study will look on to the demography of patients undergoing PCNL and their indications. The study will also compare the intensity of pain in two groups using visual analogue scale (VAS). The study will be a prospective double blinded randomized clinical trial done at Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching hospital (TUTH). The time frame of this study will be of 1 year or when sample size is fulfilled including all the patients who visit the hospital for PCNL and fulfils the inclusion criteria. At the end of our study we expect to conclude that the use of intercostal nerve block is superior or inferior than or equal to peritract infiltration in alleviating the postoperative pain following PCNL.
Detailed description
Introduction:
The incidence and prevalence of renal calculi have increased globally across all ages, sex, and race, probably due to change in dietary habits and global warming. PCNL is considered 'gold standard' for the management of large renal calculi because it is less invasive and morbid than the open surgery. Currently, the indications for PCNL include large size renal calculi (>1.5-2 cm), staghorn calculi, upper tract calculi not responding to other modalities of treatment, lower pole stones, cystine nephrolithiasis, and stones in anatomically abnormal kidneys. However, the procedure causes postoperative pain, mostly due to dilatation of the renal capsule, the parenchyma and pain along the tract of the nephrostomy tube. So the postoperative pain remains an integral part of management. Postoperative pain management not only reduces patient suffering but also improve patient satisfaction, reduces morbidity and in parallel enhances recovery, improves rehabilitation, reduces hospital stay and thereby overall hospital cost. The postoperative pain due to the procedure may vary with individual pain perception, use of percutaneous nephrostomy (PCN) tubes, comorbid conditions, choice of analgesic route, anesthetic agents and postoperative course. Small calibers of tubes, even mini PCNL or tubeless PCNL and regional analgesia such as intercostal nerve block, peritract infiltration, paravertebral block etc. could further decrease postoperative pain and analgesic requirement and hence improving postoperative patient comfort. However, studies on these techniques have produced conflicting results due to the use of different local anesthetics, various regional techniques, and different study designs. So this study aims to compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in alleviating postoperative pain following the procedure with the subjective assessment of pain
Rational/justification :
- The optimal method of pain control after percutaneous nephrolithotomy remains controversial till now.
We need better technique of analgesia to decrease the pain following PCNL.
- Intercostal nerve block and peritract infiltration are common regional analgesic methods used by most of the investigators that had shown to be adequate for postoperative pain control.
- This study may be helpful in providing evidence for a clinical guideline to manage postoperative pain that will eventually help to decrease the morbidity and bring better outcome.
General Objective :
To compare the efficacy of intercostal nerve block and peritract infiltration with 0.25% bupivacaine in percutaneous nephrolithotomy.
Specific Objective :
- To analyse the demography of the patient [age, sex, BMI, stone size and laterality, renal function test, stone burden (size, Guy's Stone score etc.)] undergoing PCNL.
- To compare the intensity of pain using visual analogue score, resting and dynamic VAS scores, following PCNL between two groups (ICNB and PTI).
- To compare the time to first rescue analgesia and total analgesic requirement between both groups.
- To document the complications of both groups.
Research Hypothesis Is Intercostal nerve block more efficacious than peritract infiltration following PCNL in alleviating pain?
Study Variables
- Independent Variables: Age, Sex, BMI, stone location, laterality and size, Guys Stone score (burden), ASA grade, comorbidity, Group I (ICBN), Group P (PTI) nephrostomy tract size (mini vs standard), no of Tracts (single vs multiple), use to tube (tube vs tubeless), length of hospital stay, stone clearance, complications
- Dependent Variables R-VAS score, D-VAS score, Time to first analgesic demand, Total analgesic requirement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- the study will be prospective double blind randomized trial using 0.25% bupivacaine in patients undergoing PCNL under one of the two arms: Intercostal Nerve block or Peritract Infiltration.
| Arm | Type | Receives |
|---|---|---|
| Intercostal Nerve Block | Experimental | Procedure: Intercostal Nerve Block• In Group I (ICBN group): Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine at the termination of PCNL under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each). |
| Peritract infiltration | Active comparator | Procedure: Peritract InfiltrationIn Group P (PTI): Single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given on completion of PCNL by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). Then the surgical wound and intervention site will be covered with an occlusive dressing. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients above 16 yrs of age undergoing PCNL in Tribhuvan University Teaching Hospital.
Key exclusion criteria (1 listed)
- Patient ≤16 years of age, known history of hypersensitivity/anaphylaxis/ contraindications to bupivacaine, Systemic Diseases (CKD, active UTI, untreated sepsis), Relook surgery, high ASA grade ( >2) unfit for anesthesia/PCNL , Contraindications for PCNL (pregnancy, coagulopathy) , Patients who decline to participate
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 |
|---|---|---|
| Intercostal Nerve BlockAlso: Regional anesthesia: Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each) | Procedure or surgery | Intercostal Nerve Block |
| Peritract InfiltrationAlso: Regional anesthesiaAt the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position). | Procedure or surgery | Peritract infiltration |
Primary outcome
Postoperative Pain Score (VAS score)
Time frame: up to 24 hours
Patients undergoing PCNL who fulfil the inclusion criteria will be identified at the time of admission. • Patients will be randomized in two groups using sealed envelope method into ICNB (group I) and PTI (group P) prior to surgery. After the procedure (intervention) the intensity of pain will be evaluated by an independent observer (the researcher or an independent ward nurse) blinded to the allocated groups at postoperative 2, 8, 12 and 24 hours. The pain score will be assessed separately by Visual Analogue Scale (VAS), a 10-point scale ranging from 0, minimum or no pain, to 10, the maximum pain score perceived or imagined by the patient, at rest (RVAS) and on deep breathing or coughing known as dynamic VAS (DVAS). •
2 secondary outcomes
Time to First Rescue analgesia
Time frame: up to 24 hours
Total Analgesic Requiremennt
Time frame: up to 24-48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 28890561Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. Indian J Anaesth. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA_88_17.
- Background: PubMed 31649454Singh I, Yadav OK, Gupta S. Efficacy of intercostal nerve block with 0.25% bupivacaine in percutaneous nephrolithotomy: A prospective randomized clinical trial. Urol Ann. 2019 Oct-Dec;11(4):363-368. doi: 10.4103/UA.UA_141_18.
- Results publication: PubMed 29288788Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27.
- choi et al , Pubmed article, PCNLLink provided by the sponsor.
- Individual participant dataSharing planned: No. After the research is completed, results will be published as Original Article in Journal. Relevant Individual data will be published in Journal itself as a part of the article.
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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.
Uttam Sharma, MS Surgery study chair
HOD, Department of Urology and Kidney Transplant Surgery, TUTH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intercostal Nerve Block and Peritract Infiltration in people with Kidney Stone, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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 Nepal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sushil Gyawali, MS Resident (+9779849742715, drsushilgyawali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (VAS score) (time frame: up to 24 hours). 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 NCT04835922, which also lists 3 linked publications.
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 8 Apr 2021.