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Comparative study between Local Anesthesia and Dorsal Muscle Anesthesia in Video Thoracic Surgery

Randomized clinical trial simple blind comparative between Local Preemptive Anesthesia and Spinal Erector Muscle in Video Thoracoscopic Thoracic Surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-109kzq9y
Enrollment
Unknown
Registered
2021-03-23
Start date
2020-11-30
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

Thoracic Diseases, lung diseases, pleural diseases, anesthesia

Interventions

Both surgical procedures and anesthetic techniques used in this study are already established and have proven efficacy and safety. It is also worth mentioning that the drugs used have release approved
E04.928.752.830

Sponsors

IGHOR RAMON PALLU DORO PEREIRA
Lead Sponsor
HOSPITAL NOSSA SENHORA DAS GRAÇAS
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients over 18 years of age, with a surgical indication for the treatment of any chest diseases, which can be performed by uni or multiport minimally invasive techniques (VATS). Patients with classification by the American Society of Anesthesiologist (ASA 1, 2 and 3)

Exclusion criteria

Exclusion criteria: Patients under 18 years of age; Patients with absolute contraindication to the surgical procedure using a minimally invasive technique (VATS); Patients who need a surgical approach that does not allow the performance of the control or intervention procedure of this research; Patients with absolute contraindication to the anesthetic drugs used in the procedure; Patients with absolute contraindication to postoperative analgesic drugs in the hospital's basic protocol (dipyrone and Bextra); Patients with a medical diagnosis of dementia, mental retardation, delirium or other conditions that affect the patient's verbal and lucid response; Pregnant patients; Patients with a current or past history of abuse of licit or illicit drugs; Emergency operation; Illiterate patients

Design outcomes

Primary

MeasureTime frame
Patients in the intervention group who underwent preemptive anesthesia of the spine - ESP block's erector muscles - reported lower pain score scores up to the seventh postoperative day than the control group. To assess the above outcome, just after the procedure, in the anesthesia recovery room, the first collection will be performed to assess the patient's pain in the immediate postoperative period. (AIRTON et al., 2016). The Numerical Verbal Scale (EVN) will be used to assess the patient's level of pain. In it, the patient will be instructed to describe in an imaginary way his pain hers in a score between 0 and 10, with zero being the absence of pain and ten being the most intense pain possible. The other collections in the hospital environment will all occur in the same way and asking the patient the same question 6, 12, and 24 hours after the procedure, as suggested by the literature (GUIRRO, 2017). In a second moment, after the patient's discharge from the hospital, it is in the interest of assessing the patient's degree of pain and his consumption of opioid medication. For this, the patient will take home an easy-to-fill form with direct questions about their degree of pain and the use of the prescribed medication. This form is separated by days after discharge and divided into 4 periods (morning, noon, afternoon, and night) because the opioid medication is prescribed for maximum use every 6 hours. At the time of consultation, the patient must bring this assessment instrument with him and return it to the responsible physician. All data collected both in the hospital evaluation forms and in the pain and medication control form will be tabulated in electronic spreadsheets for later evaluation and generation of results. The descriptive analysis will be performed through frequency tables, graphs, and numerical summary measures made in Excel and the free computer program Paleontological Statistics Software Package for Education (PAST) or similar. The results will

Secondary

MeasureTime frame
Patients in the intervention group who underwent preemptive anesthesia of the spinal erector muscles - ESP block - used lower daily doses of opioids and for less time than the control group. Soon after the procedure, in the anesthesia recovery room, the first collection will be performed to record the doses and the medication (opioid) prescribed and used by the patient. The person responsible for gathering the information will fill in the time of collection, the dose of opioid used after the surgical procedure, and the administration route. The other annotation fon information in a hospital environment will all occur in the same way after 6, 12, and 24 hours after the procedure, as suggested by the literature (GUIRRO, 2017). Always collecting data such as the location of collection, time, use of opioids between the visits, name of the medication, dose, and route of administration. In a second moment, after the patient's discharge from the hospital, it is in the interest of assessing the patient's degree of pain and his consumption of opioid medication. For this, the patient will take home an easy-to-fill form with direct questions about their degree of pain and the use of the prescribed medication (APPENDIX D). The responsible physician will fill in the form's header with the patient's number and the dosage of the opioid medication prescribed according to the standard in the post-hospital prescription field. This form is separated by days after discharge and divided into 4 periods (morning, noon, afternoon, and night) because the opioid medication is prescribed for maximum use every 6 hours. At the time of consultation, the patient must bring this assessment instrument with him and return it to the responsible physician. All data collected both in the hospital evaluation forms and in the pain and medication control form will be tabulated in electronic spreadsheets for later evaluation and generation of results. To assess the use of opioids by patients, both in t

Countries

Brazil

Contacts

Public ContactJuliano ;Ighor Ramon Souza;Pereira

;

prof.julianomendes@gmail.com;ighorpallu07@gmail.com+554133101500;+554133101500

Outcome results

None listed

Source: REBEC (via WHO ICTRP)