NCT05242198

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

February 7, 2022

Last Update Submit

December 17, 2022

Conditions

Prostatectomy

Keywords

regional anesthesiarobotic prostatectomyfascial plane blockspostoperative painurethral catheter pain

Outcome Measures

Primary Outcomes (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.

    postoperative 0 - 48 hours

Secondary Outcomes (1)

  • urethral catheter pain

    postoperative 0 - 48 hours

Study Arms (2)

Rectus sheath block group (Group R)

OTHER

Patients who underwent rectus sheath block

Procedure: Robotic prostatectomy

Control group (Group C)

OTHER

The patients that did not apply any fascial plane block

Procedure: Robotic prostatectomy

Interventions

Robotic prostatectomyPROCEDURE

patients who will undergo robotic prostatectomy

Control group (Group C)Rectus sheath block group (Group R)

Eligibility Criteria

Age18 Years - 79 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate operations are specific to the male gender only.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence of a condition preventing facial plane nerve block
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amerikan Hastanesi

Istanbul, Turkey (Türkiye)

Location

Koç Üniversitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 27486887BACKGROUND

  • 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.

    PMID: 24400824BACKGROUND

  • 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.

    PMID: 32385856BACKGROUND

  • 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.

    PMID: 31283738BACKGROUND

  • 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.

    PMID: 32945234BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sami Kaan Coşarcan

    American hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 16, 2022

Study Start

March 15, 2022

Primary Completion

August 30, 2022

Study Completion

September 21, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

TU(2)