Clinical trial NCT06620614: A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.
Official title: Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Hyperplasia, Benign
Keywords: Fractionated Dose
Heavy Bupivacaine
Spinal Anesthesia
Lead sponsor: National Academy of Medical Sciences, Nepal
Sponsor class: OTHER_GOV
First posted: 2024-10-01
Enrollment: 72
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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).

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.

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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block
timeFrame: Throughout study completion,an average of 3 months
measure: Comparision of heart rate in both participants with subarachnoid block
timeFrame: Throughout study completion,an average of 3 months
measure: Comparision of total consumption of vasopressors used during intraoperative period between the groups.
timeFrame: Throughout study completion,an average of 3 months
Secondary outcomes:
measure: Comparision of time for onset of sensory between the groups.
timeFrame: Throughout study completion,an average of 3 months.
measure: Comparision of time for onset of motor block between the groups
timeFrame: Throughout study completion,an average of 3 months.
measure: Comparision of the time of regression of sensory block between two groups.
timeFrame: Throughout study completion,an average of 3 months
measure: Comparision of the time of regression motor block between two groups.
timeFrame: Throughout study completion,an average of 3 months.
measure: Comparision of adverse effects like nausea, vomiting and shivering between the groups
timeFrame: Throughout study completion,an average of 3 months.
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: National Academy of Medical Sciences, Bir Hospital
Study officials:
affiliation: Bir Hospital
name: Pusparaj Poudel, MD
role: STUDY_CHAIR
References:
citation: Nash J. Benign prostatic hyperplasia: prevalence and diagnosis. GM Journal. 2010;40:321-4
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: Tiwari K, Masar R. Comparison Between Fractionated and Single Bolus Dose of Local Anaesthetic (Bupivacaine 0.5% Heavy) in Elective Lower Segment Caeserean Section. Int. J. Health Clin. Res. 2020; 3(6):36-42
citation: Srivastava N, Ahluwalia P, Jheetay GS, Singh G. Bolus dose versus fractionated dose injection of hyperbaric bupivacaine in spinal anaesthesia among adult patients undergoing lower limb surgery: A prospective study. Indian J Clin Anaesth. 2020;7(2):238-44
citation: Hossain MM, Biswas B, Mohanta PK, Hassan MM, Basu P, Islam F. Comparison between fractionated dose with bolus dose in Spinal Anaesthesia for haemodynamic stability and duration of analgesia in patients undergoing elective Lower Segment Caesarean Section (LSCS). Mediscope. 2020 Sep 29;7(2):95-102
citation: Sowmya NL. Comparison of Fractionated versus Bolus Dose Injection of Drug in Spinal Anaesthesia for Lower Limb Surgeries. Int. J. Sci. Res. 2020;Vol 9
citation: Mahbuba S, Chy MM, Naz S, Begum M, Jahan SS, Sheikh ZA. Comparison of sensory and motor block outcome of fractionated versus single bolus dose administration of hyperbaric bupivacaine in elective cesarean section. Medico Research Chronicles. 2021 ;8(4):317-24