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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01675895
Other study ID # DILEKLEVOBUPIVACAINE
Secondary ID
Status Completed
Phase Phase 4
First received August 24, 2012
Last updated December 17, 2012
Start date July 2009
Est. completion date July 2011

Study information

Verified date December 2012
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.


Description:

A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- elective transurethral resection of the prostate (TUR-P)

Exclusion Criteria:

- patients with contraindications for spinal anesthesia,

- known sensitivity to the study drugs,

- emergency cases, and

- patients who refused spinal anaesthesia were excluded

Study Design

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


Intervention

Drug:
Levobupivacaine lidocaine spinal anesthesia
Spinal anesthesia
levobupivacaine Spinal anesthesia
spinal anesthesia

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other maximum block level the dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes participants will be followed on the operation day No
Primary The duration of the spinal block (S1 regression of the block) the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes participanta will be followed on the operation day No
Secondary postoperative care unit stay the time between the patient entered the PACU and left the PACU (when the sensorial block was regressed to S1 dermatome and the patient fulfilled an Aldrete score higher or equal to 9), measured in minutes participants will be followed on the operation day No
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