Skip to main content
OpenTrials
Completed

NCT Number: NCT01675895

Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Benign Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine lidocaine spinal anesthesia

Drug

Spinal anesthesia

Other names: Chirocaine, Lidocaine

levobupivacaine Spinal anesthesia

Drug

spinal anesthesia

Other names: Chirocaine

Primary outcomes

  1. 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 outcomes

  1. 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

Other outcomes

  1. maximum block level

    Time frame: participants will be followed on the operation day

    the dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2012
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.