Spinal Versus Local Anesthesia for Hernia Repair

Hernia, Inguinal Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136534
• Other study ID #: 14.16 TS ComEt CBM
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: November 2021
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• spinal anesthesia
subarachnoid anesthesia with 2% hyperbaric pilicaine
• local anesthesia
(Mepivacaine 2%) performed by the surgeon before skin incision

Locations

Country	Name	City	State
Italy	CampusBioMedico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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