Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2019-01-10
2020-02-12
Brief Summary
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Detailed Description
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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,
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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group A
subarachnoid anesthesia wit hyperbaric prilocaine
spinal anesthesia
subarachnoid anesthesia with 2% hyperbaric pilicaine
group B
local anesthesia + mild sedation
local anesthesia
(Mepivacaine 2%) performed by the surgeon before skin incision
Interventions
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spinal anesthesia
subarachnoid anesthesia with 2% hyperbaric pilicaine
local anesthesia
(Mepivacaine 2%) performed by the surgeon before skin incision
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Principal Investigators
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Fabio Costa
Role: PRINCIPAL_INVESTIGATOR
Campus Bio-Medico University
Locations
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CampusBioMedico
Rome, , Italy
Countries
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References
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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.
Other Identifiers
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14.16 TS ComEt CBM
Identifier Type: -
Identifier Source: org_study_id