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

NCT ID: NCT01548794

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bupivacaine(Group B)

spinal anesthesia

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type PROCEDURE

To receive 2 ml heavy bupivacaine + 0,6 ml saline

Bupivacaine+Lidocaine (Group BL)

spinal anesthesia

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type PROCEDURE

To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.

Local Infitration Anesthesia(Group LI)

local infiltration anesthesia

Group Type ACTIVE_COMPARATOR

infiltration anesthesia

Intervention Type PROCEDURE

To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.

Interventions

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spinal anesthesia

To receive 2 ml heavy bupivacaine + 0,6 ml saline

Intervention Type PROCEDURE

spinal anesthesia

To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.

Intervention Type PROCEDURE

infiltration anesthesia

To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.

Intervention Type PROCEDURE

Other Intervention Names

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marcaine heavy marcaine heavy lidocaine marcaine lidocaine

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DILEK YAZICIOGLU

Doctor Specialist in Anesthesiology Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Yazicioglu

Role: PRINCIPAL_INVESTIGATOR

Locations

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Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18713891 (View on PubMed)

Other Identifiers

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DiskapiTRHDYAZICIOGLU

Identifier Type: -

Identifier Source: org_study_id

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