Evaluation of the effect of spinal anesthesia with combination of 0.5% hyperbaric bupivacaine 1 mg (0.2 mL)+fentanyl 20 µg (0.4 mL)+5% dextrose solution 1.4 mL (total 2 mL)on postoperative pain in transurethral resection of prostate surgery
This study design to evaluate the characteristics of selective spinal anesthesia using 0.5% hyperbaric bupivacaine 1 mg (0.2 mL)+fentanyl 20 µg (0.4 mL)+5% dextrose solution 1.4 mL (total 2 mL) in compare with hyperbaric bupivacaine 10 mg in elderly patients undergoing transurethral resection of prostate. The triple blind randomized clinical trial study will be conduct on 72 patients aged 50 to 85 years scheduled for prostatic endoscopic surgery under spinal anesthesia in Imam Reza and Razi hospitals of Birjand University of Medical Sciences. The patients will be allocated in two groups according to the type of drugs used for intrathecal injection. The Fentanyl group will receive 0.5% hyperbaric bupivacaine 0.2 mL+fentanyl 20 µg+5% dextrose 1.4 mL, and the bupivacaine group will receive 0.5% hyperbaric bupivacaine 2 ml intrathecally. Mean arterial pressure (MAP), heart rate (HR) will be measured every 5 minutes until the end of surgery and results compare at each time point between groups. The maximum motor response will be compared between two groups after achieving to the desired sensory level for TURP. Postoperative pain immediately and at 15, 30 minutes and at 2, 6, 12, 24 hours after surgery will be evaluated and compared between two groups. Also, complications such as nausea, vomiting, changes in blood pressure, and heart are compared in both groups during and after the operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081221383N8
Registration date:2017-10-17, 1396/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2017-05-23, 1396/03/02
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of spinal anesthesia with combination of 0.5% hyperbaric bupivacaine 1 mg (0.2 mL)+fentanyl 20 µg (0.4 mL)+5% dextrose solution 1.4 mL (total 2 mL)on postoperative pain in transurethral resection of prostate surgery
Public title
Using of combination of bupivacaine 1 mg and fentanyle 20 mg for spinal anesthesia in transurethral resection of prostate surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All the patients aged 50 to 85 years old with american society of anesthesia physical classificaton system (ASA) 1 or 2 who were scheduled for prostatic endoscopic surgery under spinal anesthesia.
Exclusion criteria: Patients with histories of back surgery, infection in the back, coagulopathy, hypersensitivity to local anesthetics or opioids, mental disturbance, or neurological disease were excluded.
Age
From 50 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Birjand university of medical sciences
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran.
City
Birjand
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
Ir.bums.REC.1396.46
Health conditions studied
1
Description of health condition studied
Intrathecal injection in transuretheral resection of prostat surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
postoperative pain
Timepoint
15, 30 minutes and 2, 6, 12, 24 hours after surgery
Method of measurement
visual analog scale (VAS)
2
Description
The doses of meperidine
Timepoint
Within 24 hours
Method of measurement
Based on the total dose of injections in 24 hours (questionnaire)
Secondary outcomes
1
Description
Motor block
Timepoint
When the peak sensory and cold blocks were obtained at dermatom of T10
Method of measurement
modified Bromage scale
2
Description
Nausea
Timepoint
During the surgery and immediately, 15 and 30 minutes, 2, 6, 12, 24 hours after surgery.
Method of measurement
Visual analog scale (VAS)
3
Description
Vomiting
Timepoint
During the surgery to 24 hours after surgery
Method of measurement
vomiting or not during surgery and upto 24 hours thereafter