Completed

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

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What is being tested

Levobupivacaine lidocaine spinal anesthesia

+ levobupivacaine Spinal anesthesia

Drug
Who is being recruted

Urogenital Diseases+3

+ Genital Diseases

+ Genital Diseases, Male

From 40 to 80 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2009
See protocol details

Summary

Principal SponsorDiskapi Teaching and Research Hospital
Last updated: December 18, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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).

NCT01675895
Principal SponsorDiskapi Teaching and Research Hospital
Last updated: December 18, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesProstatic Hyperplasia

Criteria

1 inclusion criteria required to participate
elective transurethral resection of the prostate (TUR-P)
4 exclusion criteria prevent from participating
emergency cases, and
known sensitivity to the study drugs
patients who refused spinal anaesthesia were excluded
patients with contraindications for spinal anesthesia

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine

Group II

Active Comparator
Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, Turkey (Türkiye)Open Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital in Google Maps
CompletedOne Study Center