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

Study Overview
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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.

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

Conditions
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Anesthesia, Inguinal Hernia

Intervention / Treatment
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* Procedure: spinal anesthesia
* Procedure: spinal anesthesia
* Procedure: infiltration anesthesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine(Group B)<br>spinal anesthesia | Procedure: spinal anesthesia<br>* To receive 2 ml heavy bupivacaine + 0,6 ml saline<br>* Other names: marcaine heavy;|
| Experimental: Bupivacaine+Lidocaine (Group BL)<br>spinal anesthesia | Procedure: spinal anesthesia<br>* To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.<br>* Other names: lidocaine;|
| Active Comparator: Local Infitration Anesthesia(Group LI)<br>local infiltration anesthesia | Procedure: infiltration anesthesia<br>* To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.<br>* Other names: lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of spinal block | 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 | The time between the end of surgery and home discharge. | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, lidocaine, local infiltration anesthesia, recovery, duration of anesthesia, outpatient herniorrhaphy, bupivacaine