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ProstatectomyNCT05242198

Rectus Sheath Block May Relieve Urethral Catheter Pain

A study testing Robotic prostatectomy in people with Prostatectomy, run by V.K.V. American Hospital, Istanbul at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to investigate the analgesic efficacy of rectus sheath block and its effect on urethral catheter discomfort in robotic prostatectomy operations. Read more about this study

Who is it for?
Ages 18 to 79 years, men only
Conditions the study is for
Prostatectomy
What is being tested?
Robotic prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Mar 2022to 21 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 - 79, the patients who will undergo robotic prostatectomy surgeries

Who cannot join

  • Presence of a condition preventing facial plane nerve block
  • Coagulopathies
  • Chronic opioid use
  • Stroke
  • Polyneuropathy
  • Patients with cognitive dysfunction
Show all 10Show fewer
  • Communication difficulties
  • Alzheimer's
  • Dementia
  • Patients who are allergic to the drugs to be used

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Amerikan Hastanesi

    Istanbul

  • Koç Üniversitesi

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF ULTRASOUND GUIDED RECTUS SHEATH BLOCK ON POSTOPERATIVE ANALGESIA AND URETHRAL CATHETER PAIN IN ROBOTIC PROSTATECTOMY OPERATIONS: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

This study aimed to investigate the analgesic efficacy of rectus sheath block and its effect on urethral catheter discomfort in robotic prostatectomy operations.

Read the detailed description

Our study will be performed on patients who will undergo elective robotic prostatectomy at the American Hospital and Koc University Hospital.All patients will be sedated with midazolam (0.02 mg/kg), following appropriate ASA monitoring and administration of oxygen by mask. All patients will be operated on under general anesthesia. Propofol (Propofol-Lipuro 10mg/ml, Braun) (2 mg/kg), fentanyl (Talinat 0.5mg, Vem İlaç) (0.8µg/kg) and rocuronium (Esmeron 10mg/ml) for the induction of general anesthesia following appropriate monitoring. Following the administration of MSD) (0.6 mg/kg), endotracheal intubation will be performed. For the maintenance of anesthesia, desflurane (Suprane, Baxter) (1 MAC) and remifentanil (Rentanil 2mg, Vem İlaç) (0.05 - 0.2 µg/kg/min) will be administered. Invasive monitoring will be performed on all patients through the radial artery cannula. Depth of anesthesia will be monitored with BIS (Bispectral Index Monitor), and BIS values will be adjusted to be 40-60. In all patients, dexamethasone (Onadron 8mg/2ml, İbrahim Etem) (4mg), ibuprofen 800mg (Intrafen 400mg, Gen İlaç) immediately after intubation and intravenous Paracetamol 1000mg (Parol, Atabay Kimya Sanayi) and Tramadol before extubation to contribute to postoperative analgesia 100 mg (Contramal, Abdi İbrahim İlaç Sanayi) will be administered. In addition, ondansetron (Zofer 4mg, Adeka) (4mg) will be administered for postoperative nausea and vomiting (PONV) prophylaxis.

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
Prostatectomy
Being tested
Robotic prostatectomy
Keywords
regional anesthesia, robotic prostatectomy, fascial plane blocks, postoperative pain, urethral catheter pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic prostatectomyProcedure or surgery

    patients who will undergo robotic prostatectomy

Study groups in NCT05242198
Study groupRoleWhat they receive
Rectus sheath block group (Group R)OtherPatients who underwent rectus sheath block
Receives: Procedure: Robotic prostatectomy
Control group (Group C)OtherThe patients that did not apply any fascial plane block
Receives: Procedure: Robotic prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative pain and postoperative morphine consumption

    The effect of rectus sheath block on postoperative pain scores and morphine consumption in patients undergoing robotic prostatectomy will be investigated.

    Measured: postoperative 0 - 48 hours

Secondary outcomes (1)
  1. urethral catheter pain

    The effect of rectus sheath block on urethral catheter pain in robotic prostatectomy operations will be investigated.

    Measured: postoperative 0 - 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2022
  2. Study start15 Mar 2022
  3. Primary completion30 Aug 2022
  4. Study completion21 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242198
Sponsor's protocol ID
Cosarcan2
Status last verified
Dec 2022
First submitted
7 Feb 2022
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27486887
  • 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.

    PubMed 24400824
  • 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.

    PubMed 32385856
  • 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.

    PubMed 31283738
  • 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.

    PubMed 32945234

Questions about this trial

What is this clinical trial studying?

A study testing Robotic prostatectomy in people with Prostatectomy, run by V.K.V. American Hospital, Istanbul at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain and postoperative morphine consumption (time frame: postoperative 0 - 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242198, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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