Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy. (TURP)

May 21, 2013 updated by: Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

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

Unknown

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

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06610
        • Diskapi Yildirim Beyazit Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Heavy Bupivacaine
7,5 mg intrathecal hyperbaric bupivacain,
Other Names:
  • marcaine heavy
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
Drug: Isobaric Bupivacaine
7.5 mg intratecal isobaric bupivacain
Other Names:
  • Marcain flakon

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

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

  • Study Director: MURAT M SAYIN, Ass. Prof, Dispapi yildirim beyazit E R hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSTAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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