Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.

NCT ID: NCT01861041

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Benign Prostate Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Heavy Bupivacaine

Intervention Type DRUG

7,5 mg intrathecal hyperbaric bupivacain,

Isobaric spinal, Local anesthetic, Amp

7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml

Group Type ACTIVE_COMPARATOR

Isobaric Bupivacaine

Intervention Type DRUG

7.5 mg intratecal isobaric bupivacain

Interventions

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Heavy Bupivacaine

7,5 mg intrathecal hyperbaric bupivacain,

Intervention Type DRUG

Isobaric Bupivacaine

7.5 mg intratecal isobaric bupivacain

Intervention Type DRUG

Other Intervention Names

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marcaine heavy Marcain flakon

Eligibility Criteria

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Inclusion Criteria

* 50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ

Exclusion Criteria

* Allergy of study drugs
* Morbid obesity
* Spinal anesthesia contrindications
* Bleeding dyscrasias
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reyhan Polat

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MURAT M SAYIN, Ass. Prof

Role: STUDY_DIRECTOR

Dispapi yildirim beyazit E R hospital

Locations

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Diskapi Yildirim Beyazit Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Murat M Sayin, Ass. Prof

Role: primary

+903125962580

References

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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.

Reference Type BACKGROUND
PMID: 21890887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19797249 (View on PubMed)

Other Identifiers

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PROSTAT

Identifier Type: -

Identifier Source: org_study_id

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