- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01861041
Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy. (TURP)
Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities.
- Group I: low dose isobaric group
- GroupII: Low dose hyperbaric group
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing TURP were randomly allocated into two groups.
- Group I: Received fentanyl 20 µgr (0.4ml),heavy bupivacaine 0.5% (1.5 ml)and normal saline % 0.9 NaCl ( 1.1ml)
- Group II: Received fentanyl 20 µgr (0.4 ml), plain bupivacaine 0.5%(1.5 ml) normal saline 0.9% NaCl (1.1 mL) in total bupivacaine 0.25% (3ml) intrathecally.
Onset and duration of the sensory block, the degree of the motor block, side - effects and perioperative analgesic requirement assesed.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06610
- Diskapi Yildirim Beyazit Education and Research Hospital
-
Contact:
- Murat M Sayin, Ass. Prof
- Phone Number: +903125962580
- Email: muratsayin@hotmail.com
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Principal Investigator:
- Reyhan POLAT, Dr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ
Exclusion Criteria:
- Allergy of study drugs
- Morbid obesity
- Spinal anesthesia contrindications
- Bleeding dyscrasias
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heavy Bupivacain, Local anesthetic, Amp
Heavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml
|
7,5 mg intrathecal hyperbaric bupivacain,
Other Names:
|
Active Comparator: Isobaric spinal, Local anesthetic, Amp
7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml
|
7.5 mg intratecal isobaric bupivacain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal Block Quality
Time Frame: 15 minute after intrathecal injection
|
Sensory block assesment with pinpric test.
|
15 minute after intrathecal injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal block regression
Time Frame: 5 minute after arrival at PACU
|
Sensory block assesment with pinprick test
|
5 minute after arrival at PACU
|
Collaborators and Investigators
Investigators
- Study Director: MURAT M SAYIN, Ass. Prof, Dispapi yildirim beyazit E R hospital
Publications and helpful links
General Publications
- Loubert C, Hallworth S, Fernando R, Columb M, Patel N, Sarang K, Sodhi V. Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study. Anesth Analg. 2011 Oct;113(4):811-7. doi: 10.1213/ANE.0b013e3182288bf2. Epub 2011 Sep 2.
- Kim SY, Cho JE, Hong JY, Koo BN, Kim JM, Kil HK. Comparison of intrathecal fentanyl and sufentanil in low-dose dilute bupivacaine spinal anaesthesia for transurethral prostatectomy. Br J Anaesth. 2009 Nov;103(5):750-4. doi: 10.1093/bja/aep263. Epub 2009 Sep 28.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROSTAT
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