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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02599623
Other study ID # RenJiH-2015
Secondary ID
Status Recruiting
Phase N/A
First received November 5, 2015
Last updated June 17, 2016
Start date January 2016
Est. completion date December 2019

Study information

Verified date June 2016
Source RenJi Hospital
Contact TAO CHEN, M.D.
Phone +8613601779874
Email dr_chentao78@163.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
China Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence rate 1 year No
Secondary Time in ICU 1 week Yes
Secondary Time to eat 1 week to 1 month Yes
Secondary Time to ambulation 1 week to 1 month Yes
Secondary Total cost 1 week to 1 month No
Secondary Complication rates 1 week to 1 month Yes
Secondary Time in hospital 1 week to 1 month Yes
Secondary Death in 30 days rate 1 month Yes
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