Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

Not Applicable

• Conditions: Anesthesia; Incarcerated Inguinal Hernia
• Interventions: Procedure: General Anesthesia; Procedure: Local Anesthesia

• Registration Number: NCT02599623
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Study Start: 2016-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age 18-70 years
2. Primary inguinal hernia
3. ASA I-II
4. Clinical diagnosis of incarcerated hernia
5. randomly select patch agreed by patients and family members

Exclusion Criteria

1. severe organ dysfunction
2. No-tolerate anesthesia
3. No-suitable for operation
4. spirit disease patients
5. automatically exit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	General Anesthesia	Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.
Local anesthesia	Local Anesthesia	Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Primary Outcome Measures

Name	Time	Method
Recurrence rate	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China