Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Incarcerated Inguinal Hernia
• Intervention / Treatment: Procedure: Local Anesthesia; Procedure: General Anesthesia

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Contact: Tao Chen, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: TAO CHEN, RenJi Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 6, 2015

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Anesthesia; Hernia; Incarcerated
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Emergencies; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: RenJiH-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED