NCT06681571

Brief Summary

In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 7, 2024

Last Update Submit

November 7, 2024

Conditions

Postoperative Pain

Keywords

transversus abdominis plane blockRectus sheath blockRobot-assisted laparoscopic prostatectomy

Outcome Measures

Primary Outcomes (1)

  • post operatif analgesia consumption

    postoperative iv-PCA tramadole dose for the first 24 hours from iv-PCA devices.

    postoperative 24 hous

Secondary Outcomes (9)

  • numerical rating scale (NRS) at rest

    popstoperative 1. hour

  • numerical rating scale (NRS) at rest

    postoperative 6. hour

  • numerical rating scale (NRS) at rest

    postoperative 16. hour

  • numerical rating scale (NRS) at rest

    postoperative 24. hour

  • NRS during coughing

    postoperative1. hour

  • +4 more secondary outcomes

Study Arms (2)

TAP Group

TAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence.

Other: TAP Block

RSB Group

RSB block will be performed immediately after the induction of anesthesia, under ultrasond guidence.

Other: RSB

Interventions

TAP BlockOTHER

TAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence.

TAP Group
RSBOTHER

Rectus Sheath block will be performed immediately after the induction of anesthesia, under Ultrasond guidence.

RSB Group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18-79 who underwent robotic radical prostatectomy and have ASA (American Society of Anesthesiologists) physical status score of 1-3.

You may qualify if:

  • Patients aged 18-79 who underwent robotic radical prostatectomy
  • Patients have ASA (American Society of Anesthesiologists) physical status score of 1-3.

You may not qualify if:

  • Patients with an allergy to local anesthetic agents
  • a platelet count below 100,000
  • INR value above 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Taninishi H, Matsusaki T, Morimatsu H. Transversus Abdominis Plane Block Reduced Early Postoperative Pain after Robot-assisted Prostatectomy: a Randomized Controlled Trial. Sci Rep. 2020 Feb 28;10(1):3761. doi: 10.1038/s41598-020-60687-y.

    PMID: 32111916BACKGROUND

  • Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.

    PMID: 35960649BACKGROUND

  • Cosarcan SK, Gurkan Y, Manici M, Ozdemir I, Kilic M, Esen T, Ercelen O. The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Apr 26;103(17):e37975. doi: 10.1097/MD.0000000000037975.

    PMID: 38669407BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Zeynep Koc

CONTACT

+905345958843zeynepyilmazkoc@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 8, 2024

Study Start

November 20, 2024

Primary Completion

January 20, 2025

Study Completion

January 30, 2025

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)