Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

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

Detailed Description
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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).

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

Conditions
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Benign Prostate Hyperplasia

Intervention / Treatment
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* Drug: Levobupivacaine lidocaine spinal anesthesia
* Drug: levobupivacaine Spinal anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Levobupivacaine lidocaine<br>Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine | Drug: Levobupivacaine lidocaine spinal anesthesia<br>* Spinal anesthesia<br>* Other names: Lidocaine;|
| Active Comparator: Group Control<br>Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline | Drug: levobupivacaine Spinal anesthesia<br>* spinal anesthesia<br>* Other names: Chirocaine;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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İntrathecal, Hyperbaric Levobupivacaine, Lidocaine, TUR-P