Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Procedure: Blind Local Anesthetic infiltration; Procedure: Transversals Fascia Block; Procedure: Spinal Anesthesia; Drug: Ropivacaine; Drug: Bupivacaine

• Registration Number: NCT03128216
• Lead Sponsor: Istituti Ospitalieri di Cremona

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-24
• Last Update Submitted: 2017-04-24
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25
• Primary Completion: 2017-07
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blind Local Anesthetic Infiltration	Blind Local Anesthetic infiltration	-
Blind Local Anesthetic Infiltration	Ropivacaine	-
Transversals Fascia Block	Transversals Fascia Block	-
Transversals Fascia Block	Ropivacaine	-
Spinal Anesthesia	Spinal Anesthesia	-
Spinal Anesthesia	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Hospital discharge	First 6 post-operative hours	Time need to reach hospital discharge criteria in post-operative period

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain	Post-operative period for 6 hours, every 30 min	NRS score in post-operative period
Intraoperative Pain Control	Intraoperative period	Need of addiction local anesthetic or endovascular anesthetic to performed surgery
Side effects	intra-operative and post-operative period (6 hours)	Incidence of side effects
Chronic Pain	at 1 week and 3 months in post-operative period	Incidence of chronic post-operative pain

Trial Locations

Locations (1)

ASST Cremona; 🇮🇹 Creom, Cremona, Italy