Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.

Benign Prostate Hyperplasia Clinical Trial

— TURP  

Official title:

Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01861041
• Other study ID #: PROSTAT
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 15, 2013
• Last updated: May 21, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: May 2013
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• 50-85 years ASA 1-4 BENIGN PROSTAT HYPERPLASI

Exclusion Criteria:

• Allergy of study drugs

• Morbid obesity

• Spinal anesthesia contrindications

• Bleeding dyscrasias

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Heavy Bupivacaine
7,5 mg intrathecal hyperbaric bupivacain,
• Isobaric Bupivacaine
7.5 mg intratecal isobaric bupivacain

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal Block Quality	Sensory block assesment with pinpric test.	15 minute after intrathecal injection	No
Secondary	Spinal block regression	Sensory block assesment with pinprick test	5 minute after arrival at PACU	No