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Assessment of the spinal anesthesia technique for benign surgery of the anus and rectum

Effectiveness of modified sacral spinal anesthesia in ambulatory hemorrhoidectomies: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5fn873
Enrollment
Unknown
Registered
2019-04-12
Start date
2018-03-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign anorectal diseases: hemorrhoids, anal fissures, and perianal fistula.

Interventions

Intervention Group A, Intervention Group A new approach to sacral spinal anesthesia called Modified Sacral Spinal Anesthesia will be performed with a patient in a seated position through a 25 or 27G Q
restriction of intravenous fluids to 100 ml of 0.9% sodium chloride
longer time of installation of the anesthetic block through the patients stay in dorsal decubitus with cephaloactivity of 25º for eight minutes after spinal anesthesia in order to sacral dispersion of
and intense reduction of intrathecal local anesthetic - 0.5% hyperbaric bupivacaine - associated with low dose of opioid as adjuvant - 20?g of fentanyl. Group B Intervention, Control Group The techniq
Procedure/surgery
E03.155.086.231

Sponsors

Universidade Federal de Alagoas
Lead Sponsor
Hospital Universitário Professor Alberto Antunes - HUPAA/UFAL
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with grade III to IV hemorrhoids, anal fissure and anorectal fistula with an indication for surgical treatment that meet the following inclusion criteria: age greater than or equal to 18 years and less than or equal to 65 years of age, with I to III American Society of Anesthesiology - ASA.

Exclusion criteria

Exclusion criteria: Contraindication to spinal anesthesia and outpatient stay (absence of telephone contact, difficulty in transportation of locomotion, physical residence in another municipality of anesthetic-surgical intervention and outpatient admission with absence of prescribed postoperative medications), current anorectal inflammatory disease, cognitive disability to respond to the forms, any decompensated clinical pathology, neurological pathology, diabetes mellitus, urge urinary incontinence, previous prostate, renal or urologic surgery and drug allergy or any contraindication to the following drugs: propofol, midazolam, dipyrone, non-hormonal anti-inflammatory drugs, paracetamol, codeine, polyresulin and cinchocaine hydrochloride.

Design outcomes

Primary

MeasureTime frame
Efficacy of modification of Sacral Spinal Anesthesia compared to Sedation associated with perineal blocks. The primary results are: the efficacy of intraoperative anesthesia, assessed through the need for anesthetic complementation and / or conversion, and the efficacy of postoperative analgesia, assessed through the Visual Analogue Scale - EVA pain in the postoperative period and specifically to the first in the techniques studied.

Secondary

MeasureTime frame
Safety of modification of Sacral Spinal Anesthesia compared to Sedation associated with perineal blocks The secondary results are: safety of intraoperative anesthesia, evaluated through the interference of anesthetic techniques used in hemodynamic repercussions (noninvasive blood pressure (NIBP, mean arterial pressure, and heart rate - HR), postoperative anesthesia safety, evaluated through the incidence of RUPO in anesthetic techniques studied and the interference of anesthesia in outpatient discharge (incidence of discharge from outpatient discharge and / or unplanned hospital admission) and user satisfaction, assessed by means of a specific form applied to the patient. RUPO was diagnosed through clinical criteria when the patient had voiding desire, but was unable to spontaneously empty the bladder at any time during the first 24 hours after the anesthetic-surgical intervention. The outpatient discharge delay was defined for this study as discharge from the medical service beyond 5 hours after the end of the anesthetic-surgical procedure. Although outpatient discharge delay can be defined as a delay of more than 12 hours after some medical intervention, the purpose of this study did not justify the stay of patients in a health service superior to that time, besides being followed through telephone contact.;User Satisfaction Evaluated through a questionnaire made by Likert's own authors.

Countries

Brazil

Contacts

Public ContactRafael Soares Santos

Hospital Universitário Professor Alberto Antunes - HUPAA/UFAL

rafaelpeterson@hotmail.com+55082981071717

Outcome results

None listed

Source: REBEC (via WHO ICTRP)