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Spinal Versus Local Anesthesia for Hernia Repair (SPINOFAST)

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
spinal anesthesia
local anesthesia
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring subarachnoid, anesthesia, prilocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: indication for inguinal hernia repair; signed informed consent

-

Exclusion Criteria: neurological disorders; allergy to local anesthetics; liver disease; serious cardiac conduction problems; severe anemia; cardiogenic or hypovolemic shock; congenital or acquired methemoglobinemia; primitive changes in coagulation; patients treated with class III antiarrhythmics (amiodarone); patients who did not suspend anticoagulants/antiplatelet agents; pregnant patients.

Sites / Locations

  • CampusBioMedico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A

group B

Arm Description

subarachnoid anesthesia wit hyperbaric prilocaine

local anesthesia + mild sedation

Outcomes

Primary Outcome Measures

Pain assessed by NRS
Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,

Secondary Outcome Measures

Full Information

First Posted
October 21, 2021
Last Updated
November 15, 2021
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT05136534
Brief Title
Spinal Versus Local Anesthesia for Hernia Repair
Acronym
SPINOFAST
Official Title
Selective Spinal Anesthesia With Hyperbaric Prilocaine Provides Better Perioperative Pain Control Than Local Anesthesia for Ambulatory Inguinal Hernia Repair Without Affecting Discharging Time: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
patients underwent inguinal hernia repair; Group A patients received Subarachnoid anesthesia; Group B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon; Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,
Detailed Description
All patients underwent inguinal hernia repair with the Trabucco's technique (15), performed by the same surgical team. Every patient was adequately informed of the procedural sequence of anesthesia and surgery and signed informed consent before being enrolled in the study. For both groups, patients received mild sedation with Midazolam 0.03 mg/kg i.v.; Paracetamol 1 gr and Ketorolac 30 mg i.v. were given before surgery as multimodal pre-emptive analgesia. Group A Subarachnoid anesthesia was performed with a 27G Whitacre needle at L2-L3 interspace, with patients on the lateral decubitus corresponding to the side of surgery. The introducer was inserted in the middle point of the space between two spinous processes, with a slightly cranial direction. The spinal needle was passed through the introducer and advanced till the subarachnoid space was reached, as confirmed by cerebrospinal fluid outflow. Subsequently, 60 mg of Prilocaine 2% were administered in the subarachnoid space, with a low-flow injection technique and the needle bevel turned laterally towards the sloping surgical side. Lateral decubitus was maintained for at least 10 minutes (16). At 15 minutes from spinal anesthesia execution, and before surgery started, sensory and motor block were assessed by ice-test and numerical 0-3 Bromage Scale, respectively. Group B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon before skin incision. Further infiltrations of local anesthetic were ensured in case of pain during the surgery, for a maximum of 400 mg of mepivacaine. In case of uncontrolled pain, fentanyl 50 mcg i.v. was given for a maximum of two intraoperative administrations. If pain persisted, a deep sedation was performed with propofol continuous i.v. infusion. Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
subarachnoid, anesthesia, prilocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
subarachnoid anesthesia wit hyperbaric prilocaine
Arm Title
group B
Arm Type
Active Comparator
Arm Description
local anesthesia + mild sedation
Intervention Type
Procedure
Intervention Name(s)
spinal anesthesia
Intervention Description
subarachnoid anesthesia with 2% hyperbaric pilicaine
Intervention Type
Procedure
Intervention Name(s)
local anesthesia
Intervention Description
(Mepivacaine 2%) performed by the surgeon before skin incision
Primary Outcome Measure Information:
Title
Pain assessed by NRS
Description
Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: indication for inguinal hernia repair; signed informed consent - Exclusion Criteria: neurological disorders; allergy to local anesthetics; liver disease; serious cardiac conduction problems; severe anemia; cardiogenic or hypovolemic shock; congenital or acquired methemoglobinemia; primitive changes in coagulation; patients treated with class III antiarrhythmics (amiodarone); patients who did not suspend anticoagulants/antiplatelet agents; pregnant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Costa
Organizational Affiliation
Campus Bio-Medico University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CampusBioMedico
City
Rome
Country
Italy

12. IPD Sharing Statement

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Spinal Versus Local Anesthesia for Hernia Repair

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