Prostatic Hyperplasia, Benign
Conditions
Keywords
Fractionated Dose, Heavy Bupivacaine, Spinal Anesthesia
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.
Interventions
COMBINATION_PRODUCT0.5% Heavy Bupivacaine
There are two groups.
Sponsors
National Academy of Medical Sciences, Nepal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block | 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 | 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. | Throughout study completion,an average of 3 months | Injection Mephentermine 6mg iv was given for hypotension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparision of the time of regression motor block between two groups. | Throughout study completion,an average of 3 months. | 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. |
| Comparision of time for onset of sensory between the groups. | Throughout study completion,an average of 3 months. | 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 |
| Comparision of adverse effects like nausea, vomiting and shivering between the groups | Throughout study completion,an average of 3 months. | Side effects managed according to hospital protocol |
| Comparision of time for onset of motor block between the groups | Throughout study completion,an average of 3 months. | Time required to reach Modified Bromage scale =3, where Bromage 0= no motor block ,Bromage 3= complete block of motor limb |
| Comparision of the time of regression of sensory block between two groups. | Throughout study completion,an average of 3 months | Loss of pinprick sensation every 30 minutes postoperatively until it reached the S2 segment |
Countries
Nepal
Outcome results
None listed