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Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

Primary Purpose

Anesthesia, Incarcerated Inguinal Hernia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Local Anesthesia

General Anesthesia

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Incarcerated, Anesthesia, Hernia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Local anesthesia

General anesthesia

Arm Description

Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Outcomes

Primary Outcome Measures

Recurrence rate

Secondary Outcome Measures

Time in ICU

Time to eat

Time to ambulation

Total cost

Complication rates

Time in hospital

Death in 30 days rate

Full Information

NCT ID

NCT02599623

First Posted

November 5, 2015

Last Updated

June 17, 2016

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02599623

Brief Title

Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RenJi Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anesthesia, Incarcerated Inguinal Hernia

Keywords

Incarcerated, Anesthesia, Hernia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Local anesthesia

Arm Type

Experimental

Arm Description

Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Arm Title

General anesthesia

Arm Type

Active Comparator

Arm Description

Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.

Intervention Type

Procedure

Intervention Name(s)

Local Anesthesia

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

General Anesthesia

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recurrence rate

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time in ICU

Time Frame

1 week

Title

Time to eat

Time Frame

1 week to 1 month

Title

Time to ambulation

Time Frame

1 week to 1 month

Title

Total cost

Time Frame

1 week to 1 month

Title

Complication rates

Time Frame

1 week to 1 month

Title

Time in hospital

Time Frame

1 week to 1 month

Title

Death in 30 days rate

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

TAO CHEN, M.D.

Phone

+8613601779874

Ext

12157918664

dr_chentao78@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

TAO CHEN

Organizational Affiliation

RenJi Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Chen, MD.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

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