NCT05136534

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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

October 21, 2021

Last Update Submit

November 15, 2021

Conditions

Hernia, Inguinal

Keywords

subarachnoidanesthesiaprilocaine

Outcome Measures

Primary Outcomes (1)

  • Pain assessed by NRS

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

    13 months

Study Arms (2)

group A

EXPERIMENTAL

subarachnoid anesthesia wit hyperbaric prilocaine

Procedure: spinal anesthesia

group B

ACTIVE COMPARATOR

local anesthesia + mild sedation

Procedure: local anesthesia

Interventions

spinal anesthesiaPROCEDURE

subarachnoid anesthesia with 2% hyperbaric pilicaine

group A
local anesthesiaPROCEDURE

(Mepivacaine 2%) performed by the surgeon before skin incision

group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CampusBioMedico

Rome, Italy

Location

Related Publications (1)

  • Costa F, Pascarella G, Luffarelli P, Strumia A, Biondo G, Piliego C, Alloni R, Agro FE. 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. J Anesth Analg Crit Care. 2022 Jan 31;2(1):6. doi: 10.1186/s44158-022-00034-x.

    PMID: 37386519DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthesia, SpinalAnesthesia, Local

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Fabio Costa

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 29, 2021

Study Start

January 10, 2019

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

IT(1)