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
60 participants
INTERVENTIONAL
2022-03-15
2022-09-21
Brief Summary
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Detailed Description
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A rectus sheath block will be applied to one group by randomization in the computer environment, and a fascial plane block will be applied to the other group. At the end of the operation, the anesthesiologist was dressed sterile before the extubation. Surgical drapes and blocks were applied in the supine position without disturbing the sterile environment. Ultrasound and liner probe was covered with a sterile drape. Rectus block, wide bandwidth, high-frequency linear probe (4-12 Mhz) (GE, LOGIQ P9 R3, Seongnam-si, Republic of Korea) and 22 Gauge, 80 mm, insulated facet needle (Pajunk GmbH, Geisingen, Germany) ) was planned. For the rectus sheath block (RB), the ultrasound probe is placed transversely at the level of the umbilicus. The rectus abdominis muscle and fascia transversalis are displayed. The needle is placed on the ultrasound probe from the lateral to the medial by in-plane technique and placed between the posterior sheath of the rectus muscle and the fascia transversalis. 20 ml of 0.25% Bupivacaine plaine (MArcaine, Sanofi İlaç A.Ş, Turkey) is administered after the fascial spread is observed under the rectus abdominis muscle using the hydro dissection technique with saline. For RB, the same procedure is applied to the other parties.
After the patients are extubated, they will be taken to the recovery unit and followed up at 0,10,30, and 60 minutes in pain scores, nausea, vomiting, and other side effects. The pain scores (postoperative pain and urethral catheter-related pain) of the patients transferred from the recovery unit to the service floor will be recorded at the 3rd hour, 6th hour, 12th hour, and 24th hour. To contribute to multimodal analgesia in service follow-ups, intravenous Paracetamol 1000 mg (Parol, Atabay Kimya Sanayi) 3\*1 and ibuprofen (Intrafen 400mg, Gene İlaç) 2x400mg will be administered.
Recovery unit (PACU) follow-up; Pain scores of all patients will be recorded at 0, 30, and 60 minutes by blind nurses for the study groups. Patients with NRS scores ≥ 4 will receive 25 µg of fentanyl. Patients with NRS scores ≥ 7 will receive 50 µg of fentanyl. Once NRS scores continue as indicated, fentanyl will be repeated at the same dose at relevant times. The total fentanyl dose requirement in the PACU will be recorded. The PACU unit will record side effects such as nausea, difficulty breathing, and tremors. Urethral catheter pain will also be questioned and recorded at the relevant specified times in the PACU unit. Intravenous morphine patient-controlled analgesia (PCA) will be started in all patients. PCA doses will be adjusted for all patients with only a bolus dose of 1 mg with a 7 min lock time. PCA bolus dose used during the PACU period will be recorded. Patients will be given pain score information for PCA use and instructed to press the bolus button if their pain is four or more.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
TRIPLE
Study Groups
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Rectus sheath block group (Group R)
Patients who underwent rectus sheath block
Robotic prostatectomy
patients who will undergo robotic prostatectomy
Control group (Group C)
The patients that did not apply any fascial plane block
Robotic prostatectomy
patients who will undergo robotic prostatectomy
Interventions
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Robotic prostatectomy
patients who will undergo robotic prostatectomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Coagulopathies
* Chronic opioid use
* Stroke
* Polyneuropathy
* Patients with cognitive dysfunction
* Communication difficulties
* Alzheimer's
* Dementia
* Patients who are allergic to the drugs to be used
18 Years
79 Years
MALE
No
Sponsors
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V.K.V. American Hospital, Istanbul
OTHER
Responsible Party
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Sami Kaan Coşarcan
Dr
Principal Investigators
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Sami Kaan Coşarcan
Role: PRINCIPAL_INVESTIGATOR
American hospital
Locations
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Amerikan Hastanesi
Istanbul, , Turkey (Türkiye)
Koç Üniversitesi
Istanbul, , Turkey (Türkiye)
Countries
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References
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Schiffmann J, Larcher A, Sun M, Tian Z, Berdugo J, Leva I, Widmer H, Lattouf JB, Zorn K, Haese A, Shariat SF, Saad F, Montorsi F, Graefen M, Karakiewicz PI. Differences in Patient Characteristics among Men Choosing Open or Robot-Assisted Radical Prostatectomy in Contemporary Practice - Analysis of Surveillance, Epidemiology, and End Results Database. Urol Int. 2017;98(1):40-48. doi: 10.1159/000447495. Epub 2016 Aug 4.
Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.
Desai N, El-Boghdadly K, Albrecht E. Epidural vs. transversus abdominis plane block for abdominal surgery - a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2021 Jan;76(1):101-117. doi: 10.1111/anae.15068. Epub 2020 May 8.
Tran DQ, Bravo D, Leurcharusmee P, Neal JM. Transversus Abdominis Plane Block: A Narrative Review. Anesthesiology. 2019 Nov;131(5):1166-1190. doi: 10.1097/ALN.0000000000002842.
Chiancone F, Fabiano M, Ferraiuolo M, de Rosa L, Prisco E, Fedelini M, Meccariello C, Visciola G, Fedelini P. Clinical implications of transversus abdominis plane block (TAP-block) for robot assisted laparoscopic radical prostatectomy: A single-institute analysis. Urologia. 2021 Feb;88(1):25-29. doi: 10.1177/0391560320957226. Epub 2020 Sep 18.
Other Identifiers
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Cosarcan2
Identifier Type: -
Identifier Source: org_study_id