Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy

April 21, 2015 updated by: DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy

The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06610
        • Diskapi Yildirim Beyazit Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having inguinal hernia
  • Not hypersensitive to study drugs
  • ASA classification I-III

Exclusion Criteria:

  • ASA classification IV-V
  • Contraindications for spinal anesthesia

Study Plan

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

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine(Group B)
spinal anesthesia
Procedure: spinal anesthesia
To receive 2 ml heavy bupivacaine + 0,6 ml saline
Other Names:
  • marcaine heavy
Procedure: spinal anesthesia
To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
Other Names:
  • lidocaine
  • marcaine heavy
EXPERIMENTAL: Bupivacaine+Lidocaine (Group BL)
spinal anesthesia
Procedure: spinal anesthesia
To receive 2 ml heavy bupivacaine + 0,6 ml saline
Other Names:
  • marcaine heavy
Procedure: spinal anesthesia
To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
Other Names:
  • lidocaine
  • marcaine heavy
ACTIVE_COMPARATOR: Local Infitration Anesthesia(Group LI)
local infiltration anesthesia
Procedure: infiltration anesthesia
To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.
Other Names:
  • lidocaine
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of spinal block
Time Frame: day of surgery
Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.
day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge time
Time Frame: Day of surgery
The time between the end of surgery and home discharge.
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Dilek Yazicioglu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiskapiTRHDYAZICIOGLU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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