Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

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

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

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Drug: Levobupivacaine lidocaine spinal anesthesia; Drug: levobupivacaine Spinal anesthesia

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group Levobupivacaine lidocaine; Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine	Drug: Levobupivacaine lidocaine spinal anesthesia; Spinal anesthesia; Other Names: Lidocaine; Chirocaine
ACTIVE_COMPARATOR: Group Control; Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline	Drug: levobupivacaine Spinal anesthesia; spinal anesthesia; Other Names: Chirocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Study Director: Taylan Akkaya, MD, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (ESTIMATE): August 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2012
• Last Update Submitted That Met QC Criteria: December 17, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Lidocaine; Hyperbaric Levobupivacaine; İntrathecal; TUR-P
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Levobupivacaine
• Other Study ID Numbers: DİLEKLEVOBUPİVACAİNE