Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02599623
• Other study ID #: RenJiH-2015
• 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

Related Conditions & MeSH terms

• Anesthesia
• Hernia
• Hernia, Inguinal
• Incarcerated Inguinal Hernia

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