AnesthesiaNCT02599623
Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery
A study testing Local Anesthesia and General Anesthesia in people with Anesthesia and Incarcerated Inguinal Hernia, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia, Incarcerated Inguinal Hernia
- What is being tested?
- Local Anesthesia and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Primary inguinal hernia
- ASA I-II
- Clinical diagnosis of incarcerated hernia
- randomly select patch agreed by patients and family members
Who cannot join
- severe organ dysfunction
- No-tolerate anesthesia
- No-suitable for operation
- spirit disease patients
- automatically exit
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Tao Chen, MD.
About this study
Official title: 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.
Read the detailed description
The outcome parameters measured included intraoperative conditions, postoperative conditions and long-term follow-up conditions.
- Conditions
- Anesthesia, Incarcerated Inguinal Hernia
- Being tested
- Local Anesthesia, General Anesthesia
- Keywords
- Incarcerated, Anesthesia, Hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local AnesthesiaProcedure or surgery
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 AnesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia | Experimental | Patient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed. Receives: Procedure: Local Anesthesia |
| General anesthesia | Active comparator | Patient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed. Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: 1 year
Secondary outcomes (7)
Time in ICU
Measured: 1 week
Time to eat
Measured: 1 week to 1 month
Time to ambulation
Measured: 1 week to 1 month
Total cost
Measured: 1 week to 1 month
Complication rates
Measured: 1 week to 1 month
Time in hospital
Measured: 1 week to 1 month
Death in 30 days rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TAO CHEN, RenJi Hospital
- Investigators
- TAO CHEN, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599623
- Sponsor's protocol ID
- RenJiH-2015
- Status last verified
- Jun 2016
- First submitted
- 5 Nov 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery, a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02599623
- Acronym / sponsor ID
- RenJiH-2015
- Conditions
- Anesthesia, Incarcerated Inguinal Hernia
- Keywords
- Incarcerated, Anesthesia, Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The outcome parameters measured included intraoperative conditions, postoperative conditions and long-term follow-up conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia | Experimental | Procedure: Local AnesthesiaPatient operated in local anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed. |
| General anesthesia | Active comparator | Procedure: General AnesthesiaPatient operated in general anesthesia, with a mesh repair in Lichtenstein if no bowel necrosis existed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years
- Primary inguinal hernia
- ASA I-II
- Clinical diagnosis of incarcerated hernia
- randomly select patch agreed by patients and family members
Key exclusion criteria (5 listed)
- severe organ dysfunction
- No-tolerate anesthesia
- No-suitable for operation
- spirit disease patients
- automatically exit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local AnesthesiaPatients 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. | Procedure or surgery | Local anesthesia |
| General AnesthesiaIn 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. | Procedure or surgery | General anesthesia |
Primary outcome
Recurrence rate
Time frame: 1 year
7 secondary outcomes
Time in ICU
Time frame: 1 week
Time to eat
Time frame: 1 week to 1 month
Time to ambulation
Time frame: 1 week to 1 month
Total cost
Time frame: 1 week to 1 month
Complication rates
Time frame: 1 week to 1 month
Time in hospital
Time frame: 1 week to 1 month
Death in 30 days rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TAO CHEN study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthesia and General Anesthesia in people with Anesthesia and Incarcerated Inguinal Hernia, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAO CHEN, M.D. (+8613601779874 ext. 12157918664, dr_chentao78@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.