Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02599623

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Incarcerated Inguinal Hernia	Procedure: Local Anesthesia Procedure: General Anesthesia	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Local anesthesia Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.	Procedure: 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.
Active Comparator: General anesthesia Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed.	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.

Arm

Intervention/Treatment

Experimental: Local anesthesia

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

Procedure: 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.

Active Comparator: General anesthesia

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

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.

Outcome Measures

Primary Outcome Measures

Recurrence rate [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai		China

Sponsors and Collaborators

RenJi Hospital

Investigators

Study Chair: TAO CHEN, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TAO CHEN, attending doctor, RenJi Hospital

ClinicalTrials.gov Identifier:

NCT02599623

Other Study ID Numbers:

RenJiH-2015

First Posted:

Nov 6, 2015

Last Update Posted:

Jun 20, 2016

Last Verified:

Jun 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by TAO CHEN, attending doctor, RenJi Hospital

Incarcerated

Anesthesia

Hernia

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 20, 2016