Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

Study Overview
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Brief Summary
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This prospective randomized is designed to evaluate the safety and efficacy of hernia repairs using local anesthesia compared with those using general anesthesia for patients with incarcerated hernia.

Detailed Description
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The outcome parameters measured included intraoperative conditions, postoperative conditions and long-term follow-up conditions.

Official Title
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Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery, a Prospective Randomized Trial

Conditions
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Anesthesia, Incarcerated Inguinal Hernia

Intervention / Treatment
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* Procedure: Local Anesthesia
* Procedure: General Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years Primary inguinal hernia ASA I-II Clinical diagnosis of incarcerated hernia randomly select patch agreed by patients and family members Exclusion Criteria: severe organ dysfunction No-tolerate anesthesia No-suitable for operation spirit disease patients automatically exit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local anesthesia<br>Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed. | Procedure: Local Anesthesia<br>* Patients in LA group received the local infiltration technique. A mixture of 2% lidocaine 20ml and 0.9%NS 30ml was used as the local anesthetic. Patients required extra analgesia during the surgery were given 20-40mg parecoxib sodium intravenously. Conversion to GA was performed if LA was intolerant for patient, which was evaluated by both anesthetists and surgeons.<br>|
| Active Comparator: General anesthesia<br>Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed. | Procedure: General Anesthesia<br>* In group GA, anesthesia was induced with propofol 2mg/kg and fentanyl 0.1-0.2mg intravenously. Inhalation anesthesia was given at the same time with a mixture of oxygen and isoflurane 1-2% through an intubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in ICU |  | 1 week | 
| Time to eat |  | 1 week to 1 month | 
| Time to ambulation |  | 1 week to 1 month | 
| Total cost |  | 1 week to 1 month | 
| Complication rates |  | 1 week to 1 month | 
| Time in hospital |  | 1 week to 1 month | 
| Death in 30 days rate |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incarcerated, Anesthesia, Hernia