search
Back to results

Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

Primary Purpose

Benign Prostate Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Levobupivacaine lidocaine spinal anesthesia
levobupivacaine Spinal anesthesia
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia focused on measuring Hyperbaric Levobupivacaine, İntrathecal, Lidocaine, TUR-P

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Levobupivacaine lidocaine

Group Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2012
Last Updated
December 17, 2012
Sponsor
Diskapi Teaching and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01675895
Brief Title
Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration
Official Title
Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
Keywords
Hyperbaric Levobupivacaine, İntrathecal, Lidocaine, TUR-P

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Levobupivacaine lidocaine
Arm Type
Experimental
Arm Description
Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
Arm Title
Group Control
Arm Type
Active Comparator
Arm Description
Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine lidocaine spinal anesthesia
Other Intervention Name(s)
Chirocaine, Lidocaine
Intervention Description
Spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
levobupivacaine Spinal anesthesia
Other Intervention Name(s)
Chirocaine
Intervention Description
spinal anesthesia
Primary Outcome Measure Information:
Title
The duration of the spinal block (S1 regression of the block)
Description
the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes
Time Frame
participanta will be followed on the operation day
Secondary Outcome Measure Information:
Title
postoperative care unit stay
Description
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
Time Frame
participants will be followed on the operation day
Other Pre-specified Outcome Measures:
Title
maximum block level
Description
the dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes
Time Frame
participants will be followed on the operation day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taylan Akkaya, MD
Organizational Affiliation
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Official's Role
Study Director
Facility Information:
Facility Name
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18713891
Citation
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.
Results Reference
background

Learn more about this trial

Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

We'll reach out to this number within 24 hrs