Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

Overview

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

Full Title of Study: “Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 2011

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).

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Group Levobupivacaine lidocaine
    • Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
  • Active Comparator: Group Control
    • Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline

Clinical Trial Outcome Measures

Primary Measures

  • The duration of the spinal block (S1 regression of the block)
    • Time Frame: participanta will be followed on the operation day
    • the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes

Secondary Measures

  • postoperative care unit stay
    • Time Frame: participants will be followed on the operation day
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Diskapi Teaching and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: DILEK YAZICIOGLU, Principal investigator – Diskapi Teaching and Research Hospital
  • Overall Official(s)
    • Taylan Akkaya, MD, Study Director, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

References

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.

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