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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01548794
First received: March 6, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Anesthesia
Inguinal Hernia
Procedure: spinal anesthesia
Procedure: infiltration anesthesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • Duration of spinal block [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.


Secondary Outcome Measures:
  • Discharge time [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    The time between the end of surgery and home discharge.


Enrollment: 93
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine(Group B)
spinal anesthesia
Procedure: spinal anesthesia
To receive 2 ml heavy bupivacaine + 0,6 ml saline
Other Name: marcaine heavy
Experimental: Bupivacaine+Lidocaine (Group BL)
spinal anesthesia
Procedure: spinal anesthesia
To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
Other Names:
  • marcaine heavy
  • lidocaine
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:
  • marcaine
  • lidocaine

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548794

Locations
Turkey
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Turkey, 06610
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Dilek Yazicioglu
  More Information

Publications:
Responsible Party: DILEK YAZICIOGLU, Doctor Specialist in Anesthesiology Principal investigator, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01548794     History of Changes
Other Study ID Numbers: DiskapiTRHDYAZICIOGLU
Study First Received: March 6, 2012
Last Updated: December 17, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Diskapi Teaching and Research Hospital:
spinal anesthesia
bupivacaine
lidocaine
local infiltration anesthesia
recovery
duration of anesthesia
outpatient herniorrhaphy

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Bupivacaine
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014