Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

NCT ID: NCT02599623

Last Updated: 2016-06-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

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.

Conditions

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Anesthesia Incarcerated Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Local anesthesia

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

Group Type EXPERIMENTAL

Local Anesthesia

Intervention Type PROCEDURE

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.

General anesthesia

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

Group Type ACTIVE_COMPARATOR

General Anesthesia

Intervention Type PROCEDURE

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.

Interventions

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Local Anesthesia

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

General Anesthesia

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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TAO CHEN

attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TAO CHEN

Role: STUDY_CHAIR

RenJi Hospital

Locations

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

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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TAO CHEN, M.D.

Role: CONTACT

+8613601779874 ext. 12157918664

Facility Contacts

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Tao Chen, MD.

Role: primary

Other Identifiers

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RenJiH-2015

Identifier Type: -

Identifier Source: org_study_id

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