Prostatic Hyperplasia, BenignPhase 1NCT06620614

A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.

A Phase 1 study testing 0.5% Heavy Bupivacaine in people with Prostatic Hyperplasia, Benign, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing Transurethral Resection of Prostate(TURP) surgery under Subarachnoid block(SAB). Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Prostatic Hyperplasia, Benign
What is being tested?: 0.5% Heavy Bupivacaine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteNepal
Study dates: 1 Oct 2022to 1 Dec 2023
Phase: Phase 1
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 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 50 years and above patients undergoing TURP surgery under SAB
American Society of Anesthesiologist's Physical Status: I and II.

Who cannot join

Patients with history of uncontrolled hypertension.
Patients with previous history of cerebrovascular accidents.
Patients with history of spinal deformity.
Patients with known allergy to local anesthetics.
Patient with Infection at site of injection.
Patient with history of coagulopathy.

Trial locations and contacts

1 site in 1 country.

Nepal1 site

National Academy of Medical Sciences, Bir Hospital
Kathmandu, +977

Other trials in Nepal

About this study

Official title: Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.

Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

Read the detailed description

The aim of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing TURP surgery under SAB.

Seventy-two patients aged 50 years and above belonging to American Physical status I and II undergoing transurethral resection of prostate for benign enlargement of prostate under subarachnoid block are enrolled and are divided into two groups having 36 patients in each.

Intraoperative mean arterial pressure (MAP), heart rate, onset of sensory and motor block, duration of sensory and motor block, and total intraoperative consumption of vasopressor are observed and compared between the groups.

Conditions: Prostatic Hyperplasia, Benign
Being tested: 0.5% Heavy Bupivacaine
Keywords: Fractionated Dose, Heavy Bupivacaine, Spinal Anesthesia
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.5% Heavy BupivacaineCombination product
Also called 26 G Quincke's needle
There are two groups.

Study groups in NCT06620614
Study group	Role	What they receive
Fractionated group arm	Experimental	In this group ,participants are given 1.6 ml of Injection Heavy Bupivacaine 0.5% initially followed by 0.9ml after 60 seconds at a rate of 0.2ml/hr. Receives: Combination Product: 0.5% Heavy Bupivacaine
Bolus arm group	Placebo comparator	In this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr Receives: Combination Product: 0.5% Heavy Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block
Hypotension was defined when mean arterial pressure (MAP) decreased ≤20% from baseline.
Measured: Throughout study completion,an average of 3 months
Comparision of heart rate in both participants with subarachnoid block
Bradycardia was defined when heart rate is less than 60 beats per minute.
Measured: Throughout study completion,an average of 3 months
Comparision of total consumption of vasopressors used during intraoperative period between the groups.
Injection Mephentermine 6mg iv was given for hypotension
Measured: Throughout study completion,an average of 3 months

Secondary outcomes (5)

Comparision of time for onset of sensory between the groups.
Sensory block was assessed by loss of sensation to pinprick with blunted tip needle bilaterally in the dermatomal levels. It was tested every 3 min until achievement of maximum sensory block i.e. till T10 level
Measured: Throughout study completion,an average of 3 months.
Comparision of time for onset of motor block between the groups
Time required to reach Modified Bromage scale =3, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb
Measured: Throughout study completion,an average of 3 months.
Comparision of the time of regression of sensory block between two groups.
Loss of pinprick sensation every 30 minutes postoperatively until it reached the S2 segment
Measured: Throughout study completion,an average of 3 months
Comparision of the time of regression motor block between two groups.
Assessed every 30 minutes postoperatively Time required to reach Modified Bromage scale =0, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb.
Measured: Throughout study completion,an average of 3 months.
Comparision of adverse effects like nausea, vomiting and shivering between the groups
Side effects managed according to hospital protocol
Measured: Throughout study completion,an average of 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20221 Dec 2023

First posted1 Oct 2024
Study start1 Oct 2022
Primary completion1 Dec 2022
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Prostatic Hyperplasia, BenignStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: An approval from the Institutional Review Board (IRB), NAMS was taken prior to commencing the study. 72 Patients of ASA physical status I or II scheduled for Transurethral Resection of prostate under Sub-arachnoid block were enrolled in the study. . Patient's characteristics including name, gender, age, body weight, height and body mass index were recorded. Patients were kept nil per oral as per American society of anesthesiologist guidelines prior to surgery. Study pouplation were divided into two groups: * Bolus group * Fractionated group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06620614
Sponsor's protocol ID: 187/2079/80
Status last verified: Oct 2024
First submitted: 20 Sep 2024
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Nash J. Benign prostatic hyperplasia: prevalence and diagnosis. GM Journal. 2010;40:321-4
Persu C, Georgescu D, Arabagiu I, Cauni V, Moldoveanu C, Geavlete P. TURP for BPH. How large is too large? J Med Life. 2010 Oct-Dec;3(4):376-80.
PubMed 21254734
Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497.
PubMed 26240544
Gandhi M, Kabir KK, Arora KK, Tiwari K. Comparative study between fractionated and single bolus dose of local anaesthetic in elective lower segment caeserean section. Indian J Clin Anaesth. 2019;6(3):386-90
Kararmaz A, Kaya S, Turhanoglu S, Ozyilmaz MA. Low-dose bupivacaine-fentanyl spinal anaesthesia for transurethral prostatectomy. Anaesthesia. 2003 Jun;58(6):526-30. doi: 10.1046/j.1365-2044.2003.03153.x.
PubMed 12846615
Beed M. Anaesthesia for gynaecological and genitourinary surgery. In: Aitkenhead A, Thompson J, Rowbotham D, Moppett I, editors. Smith and Aitkenhead's Textbook of Anaesthesia. 6 th edition. London: Churchill Livingstone/Elsevier; 2013. p. 568-77
Puri N, Talwar A. Comparative Study of Ephedrine and Mephertermine in Treatment of Hypotension in Patients Undergoing Elective Trans Urethral Resection Prostate (TURP). Journal of Bangladesh College of Physicians and Surgeons. 2010;28(1):10-6
Favarel-Garrigues JF, Sztark F, Petitjean ME, Thicoipe M, Lassie P, Dabadie P. Hemodynamic effects of spinal anesthesia in the elderly: single dose versus titration through a catheter. Anesth Analg. 1996 Feb;82(2):312-6. doi: 10.1097/00000539-199602000-00017.
PubMed 8561333
Nugroho AM, Sugiarto A, Chandra S, Lembahmanah L, Septica RI, Yuneva A. A Comparative Study of Fractionated Versus Single Dose Injection for Spinal Anesthesia During Cesarean Section in Patients with Pregnancy-Induced Hypertension. Anesth Pain Med. 2019 Feb 6;9(1):e85115. doi: 10.5812/aapm-85115. eCollection 2019 Feb.
PubMed 30881909
Norris MC. Neuraxial anaesthesia. In: Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC, Ortega R, Sharar SM, Holt NF, editors. Clinical Anaesthesia. 8 thedition. New Delhi: Wolters Kluwer; 2017. p. 914-44.
Brull R, Macfarlane AJ, Chan VW. Spinal, epidural, and caudal anaesthesia. In: Miller RD, editor. Miller's anaesthesia. 8 th edition. Philadelphia: Elsevier Saunders;2015. p. 1684-720.
Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth. 2017 Jan;61(1):55-60. doi: 10.4103/0019-5049.198390.
PubMed 28216705
Ramasali M.V., Vankaylapatti S. D., Appagalla S, Kulkarni D. K., Pasupuleti S. A Prospective Randomised Double-Blind Comparative Study of Bolus versus Fractionated Dose Injection in Spinal Anaesthesia for Pregnant Women undergoing elective Caesarean Section. Indian J Anesth Anal 2018; 5(11):1840-45
Derakhshan P, Faiz SHR, Rahimzadeh P, Salehi R, Khaef G. A Comparison of the Effect of Fractionated and Bolus Dose Injection on Spinal Anesthesia for Lower Limb Surgery: A Randomized Clinical Trial. Anesth Pain Med. 2020 Aug 23;10(5):e102228. doi: 10.5812/aapm.102228. eCollection 2020 Oct.
PubMed 34150559
Kaniyil S, Priya PG, Nithinkumar MP, Sneha SR. Fractional spinal anaesthesia in high-risk elderly patients for orthopaedic surgery - Case series. Indian J Anaesth. 2023 Jul;67(7):651-654. doi: 10.4103/ija.ija_888_22. Epub 2023 Jul 14.
PubMed 37601939

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostatic Hyperplasia, Benign trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.
ClinicalTrials.gov ID: NCT06620614
Acronym / sponsor ID: 187/2079/80
Conditions: Prostatic Hyperplasia, Benign
Keywords: Fractionated Dose, Heavy Bupivacaine, Spinal Anesthesia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: National Academy of Medical Sciences, NepalOther government
Study start: 1 Oct 2022 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 1 Oct 2024 (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.

Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: An approval from the Institutional Review Board (IRB), NAMS was taken prior to commencing the study. 72 Patients of ASA physical status I or II scheduled for Transurethral Resection of prostate under Sub-arachnoid block were enrolled in the study. . Patient's characteristics including name, gender, age, body weight, height and body mass index were recorded. Patients were kept nil per oral as per American society of anesthesiologist guidelines prior to surgery. Study pouplation were divided into two groups: * Bolus group * Fractionated group

Arm	Type	Receives
Fractionated group arm	Experimental	Combination Product: 0.5% Heavy BupivacaineIn this group ,participants are given 1.6 ml of Injection Heavy Bupivacaine 0.5% initially followed by 0.9ml after 60 seconds at a rate of 0.2ml/hr.
Bolus arm group	Placebo comparator	Combination Product: 0.5% Heavy BupivacaineIn this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age: 50 years and above patients undergoing TURP surgery under SAB
American Society of Anesthesiologist's Physical Status: I and II.

Key exclusion criteria (6 listed)

Patients with history of uncontrolled hypertension.
Patients with previous history of cerebrovascular accidents.
Patients with history of spinal deformity.
Patients with known allergy to local anesthetics.
Patient with Infection at site of injection.

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
0.5% Heavy BupivacaineAlso: 26 G Quincke's needleThere are two groups.	Combination product	Bolus arm group, Fractionated group arm

Primary outcome

Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block
Time frame: Throughout study completion,an average of 3 months
Hypotension was defined when mean arterial pressure (MAP) decreased ≤20% from baseline.
Comparision of heart rate in both participants with subarachnoid block
Time frame: Throughout study completion,an average of 3 months
Bradycardia was defined when heart rate is less than 60 beats per minute.
Comparision of total consumption of vasopressors used during intraoperative period between the groups.
Time frame: Throughout study completion,an average of 3 months
Injection Mephentermine 6mg iv was given for hypotension

5 secondary outcomes

Comparision of time for onset of sensory between the groups.
Time frame: Throughout study completion,an average of 3 months.
Comparision of time for onset of motor block between the groups
Time frame: Throughout study completion,an average of 3 months.
Comparision of the time of regression of sensory block between two groups.
Time frame: Throughout study completion,an average of 3 months
Comparision of the time of regression motor block between two groups.
Time frame: Throughout study completion,an average of 3 months.
Comparision of adverse effects like nausea, vomiting and shivering between the groups
Time frame: Throughout study completion,an average of 3 months.

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 8 Oct 2024.
BackgroundNash J. Benign prostatic hyperplasia: prevalence and diagnosis. GM Journal. 2010;40:321-4
Background: PubMed 21254734Persu C, Georgescu D, Arabagiu I, Cauni V, Moldoveanu C, Geavlete P. TURP for BPH. How large is too large? J Med Life. 2010 Oct-Dec;3(4):376-80.
Background: PubMed 26240544Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497.
BackgroundGandhi M, Kabir KK, Arora KK, Tiwari K. Comparative study between fractionated and single bolus dose of local anaesthetic in elective lower segment caeserean section. Indian J Clin Anaesth. 2019;6(3):386-90
Background: PubMed 12846615Kararmaz A, Kaya S, Turhanoglu S, Ozyilmaz MA. Low-dose bupivacaine-fentanyl spinal anaesthesia for transurethral prostatectomy. Anaesthesia. 2003 Jun;58(6):526-30. doi: 10.1046/j.1365-2044.2003.03153.x.
BackgroundBeed M. Anaesthesia for gynaecological and genitourinary surgery. In: Aitkenhead A, Thompson J, Rowbotham D, Moppett I, editors. Smith and Aitkenhead's Textbook of Anaesthesia. 6 th edition. London: Churchill Livingstone/Elsevier; 2013. p. 568-77
BackgroundPuri N, Talwar A. Comparative Study of Ephedrine and Mephertermine in Treatment of Hypotension in Patients Undergoing Elective Trans Urethral Resection Prostate (TURP). Journal of Bangladesh College of Physicians and Surgeons. 2010;28(1):10-6
Background: PubMed 8561333Favarel-Garrigues JF, Sztark F, Petitjean ME, Thicoipe M, Lassie P, Dabadie P. Hemodynamic effects of spinal anesthesia in the elderly: single dose versus titration through a catheter. Anesth Analg. 1996 Feb;82(2):312-6. doi: 10.1097/00000539-199602000-00017.
Background: PubMed 30881909Nugroho AM, Sugiarto A, Chandra S, Lembahmanah L, Septica RI, Yuneva A. A Comparative Study of Fractionated Versus Single Dose Injection for Spinal Anesthesia During Cesarean Section in Patients with Pregnancy-Induced Hypertension. Anesth Pain Med. 2019 Feb 6;9(1):e85115. doi: 10.5812/aapm-85115. eCollection 2019 Feb.
BackgroundNorris MC. Neuraxial anaesthesia. In: Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC, Ortega R, Sharar SM, Holt NF, editors. Clinical Anaesthesia. 8 thedition. New Delhi: Wolters Kluwer; 2017. p. 914-44.
BackgroundBrull R, Macfarlane AJ, Chan VW. Spinal, epidural, and caudal anaesthesia. In: Miller RD, editor. Miller's anaesthesia. 8 th edition. Philadelphia: Elsevier Saunders;2015. p. 1684-720.
Background: PubMed 28216705Badheka JP, Oza VP, Vyas A, Baria D, Nehra P, Babu T. Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised, double-blind study. Indian J Anaesth. 2017 Jan;61(1):55-60. doi: 10.4103/0019-5049.198390.
This study describes about prevalence of benign prostatic hyperlasia in elderly male.Link provided by the sponsor.
This article describes about TURP for Benign Prostatic HyperplasiaLink provided by the sponsor.
This article describes about comparision between saddle and subarachnoid block in TURP surgery.Link provided by the sponsor.
This article describes about Low-dose bupivacaine-fentanyl spinal anaesthesia for transurethral prostatectomy.Link provided by the sponsor.
This is academic book of anesthesiaLink provided by the sponsor.
This study describes about comparison of Ephedrine and Mephertermine in Treatment of Hypotension in Patients Undergoing Elective Trans Urethral Resection Prostate (TURP).Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Pusparaj Poudel, MD study chair

Bir Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.5% Heavy Bupivacaine in people with Prostatic Hyperplasia, Benign, run by National Academy of Medical Sciences, Nepal 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 2 inclusion and 6 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 8 Oct 2024. 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. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block (time frame: Throughout study completion,an average of 3 months). The study lists 3 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 NCT06620614, which also lists 20 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 Oct 2024.