Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.

Phase 4

• Conditions: Benign Prostate Hyperplasia
• Interventions: Drug: Heavy Bupivacaine; Drug: Isobaric Bupivacaine

• Registration Number: NCT01861041
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-21
• Last Update Submitted: 2013-05-21
• Study First Posted: 2013-05-23
• Last Update Posted: 2013-05-23
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heavy Bupivacain, Local anesthetic, Amp	Heavy Bupivacaine	Heavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml
Isobaric spinal, Local anesthetic, Amp	Isobaric Bupivacaine	7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml

Primary Outcome Measures

Name	Time	Method
Spinal Block Quality	15 minute after intrathecal injection	Sensory block assesment with pinpric test.

Secondary Outcome Measures

Name	Time	Method
Spinal block regression	5 minute after arrival at PACU	Sensory block assesment with pinprick test

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Education and Research Hospital; 🇹🇷 Ankara, Turkey