Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

Inguinal Hernia Clinical Trial

Official title:

Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03128216
• Other study ID #: ANECR_02_17
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2017
• Last updated: April 24, 2017
• Start date: April 2017
• Est. completion date: September 2017

Study information

• Verified date: April 2017
• Source: Istituti Ospitalieri di Cremona
• Contact: Erika Basso Ricci, M.D.
• Phone: +3903724050
• Email: e.bassoricci[@]asst-cremona.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age> 18 years;

• ASA score I - II - III;

• patients undergoing elective inguinal hernia repair;

• signed informed consent;

Exclusion Criteria:

• chronic therapy with opioids/ antidepressants;

• urgent/emergent surgery;

• postoperative transfer to the intensive care unit;

• known allergy to any drug medication;

• local skin infection;

• epilepsy;

• alcohol or drug abuse;

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Blind Local Anesthetic infiltration
Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.
• Transversals Fascia Block
Patients of this group received ultrasound guided omolateral Transversals Fascia Block.
• Spinal Anesthesia
Patients of this group received Spinal Anesthesia

Drug:
• Ropivacaine
Local anesthetic used for local infiltration and Transversals fascia block
• Bupivacaine
Local anesthetic used for Spinal Anesthesia

Locations

Country	Name	City	State
Italy	ASST Cremona	Creom	Cremona

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Ospitalieri di Cremona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital discharge	Time need to reach hospital discharge criteria in post-operative period	First 6 post-operative hours
Secondary	Intraoperative Pain Control	Need of addiction local anesthetic or endovascular anesthetic to performed surgery	Intraoperative period
Secondary	Post-operative Pain	NRS score in post-operative period	Post-operative period for 6 hours, every 30 min
Secondary	Side effects	Incidence of side effects	intra-operative and post-operative period (6 hours)
Secondary	Chronic Pain	Incidence of chronic post-operative pain	at 1 week and 3 months in post-operative period