Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

Benign Prostate Hyperplasia Clinical Trial

Official title:

Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675895
• Other study ID #: DILEKLEVOBUPIVACAINE
• 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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

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