SPINOFAST: Spinal Versus Local Anesthesia for Hernia Repair

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Completed

CT.gov ID

NCT05136534

Collaborator

(none)

132

Enrollment

Location

Arms

13.1

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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,

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal	Procedure: spinal anesthesia Procedure: local anesthesia	N/A

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,

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 10, 2019

Actual Primary Completion Date :

Feb 12, 2020

Actual Study Completion Date :

Feb 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A subarachnoid anesthesia wit hyperbaric prilocaine	Procedure: spinal anesthesia subarachnoid anesthesia with 2% hyperbaric pilicaine
Active Comparator: group B local anesthesia + mild sedation	Procedure: local anesthesia (Mepivacaine 2%) performed by the surgeon before skin incision

Arm

Intervention/Treatment

Experimental: group A

subarachnoid anesthesia wit hyperbaric prilocaine

Procedure: spinal anesthesia

subarachnoid anesthesia with 2% hyperbaric pilicaine

Active Comparator: group B

local anesthesia + mild sedation

Procedure: local anesthesia

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

Outcome Measures

Primary Outcome Measures

Pain assessed by NRS [13 months]
Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.