NCT06975735

Brief Summary

Regional anesthetics, nerve blocks, and interfascial blocks are becoming more common in many types of surgery to help with pain after surgery. Most clinicians concur with the importance of reducing postoperative pain scores and facilitating early discharge. The transversalis fascia plane block (TFP) and transversus abdominis plane block (TA), which are done from the side of the abdomen, have been proven to be very useful in surgeries related to women's health, weight loss, and the colon. Research on the effectiveness of both procedures in robot-assisted laparoscopic prostatectomies (RALP) is insufficient. The aim was to see if using a transversalis fascia plane block (TFP) or a transversus abdominal plane (TAP) block with 0.25% bupivacaine helped reduce pain, speed up recovery, and shorten hospital stays for men undergoing robot-assisted radical prostatectomy (RALP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

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

May 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

May 25, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

May 9, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

prostatectomy, pain

Outcome Measures

Primary Outcomes (1)

  • Reducing patient-controlled analgesic consumption

    The time to first analgesic request in the postoperative period

    From the patient's anesthesia induction in the operating room to the postoperative 24. hours

Study Arms (3)

TAP Group

ACTIVE COMPARATOR

Receiving TAP 20 ml bupivacaine 0.25%

Procedure: TAP Plane Block

TFP Group

ACTIVE COMPARATOR

Receiving TFP 20 ml bupivacaine 0.25%

Procedure: TFP Block

Control Group

NO INTERVENTION

Not receiving TAP or TFP

Interventions

The transversus abdominis plane block (TAPB) is a technically simple and safe form of regional anesthesia that can provide effective analgesia for 12 hours in patients with acute postoperative pain

Also known as: TAP Block
TAP Group
TFP BlockPROCEDURE

The transversalis fascia plane block (TAPB) is a technically simple and safe form of regional anesthesia that can provide effective analgesia for 12 hours in patients with acute postoperative pain

TFP Group

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly male patients
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) Class I or II
  • Having regular preoperative visits

You may not qualify if:

  • Patients classified as ASA III or IV,
  • Patients with coagulopathy
  • Those with a history of allergies
  • Significant Cardiac Disorders (Coronary Artery Disease, Arrhythmia, Electrocardiography Anomaly, Heart Failure, etc.)
  • \. Those with bleeding diathesis and those receiving anticoagulant therapy 2. Those with a history of carotid artery stenosis, 3. Cardiovascular disease, 4. Hipertansiyon, 5. Chronic obstructive pulmonary disease, 6. Patients with a heart rhythm outside the sinus 7. Patients with a history of cerebrovascular disease 8. Alcoholism or psychiatric illness 9. Those with diabetes, 10. Contraindicated for TAP and TFP Block 11. Those with drug allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kudret Doğru

Kayseri, Melikgazi, 38050, Turkey (Türkiye)

Location

Related Publications (2)

  • Dal Moro F, Aiello L, Pavarin P, Zattoni F. Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study. J Robot Surg. 2019 Feb;13(1):147-151. doi: 10.1007/s11701-018-0858-6. Epub 2018 Jul 28.

    PMID: 30056612BACKGROUND
  • Cacciamani GE, Menestrina N, Pirozzi M, Tafuri A, Corsi P, De Marchi D, Inverardi D, Processali T, Trabacchin N, De Michele M, Sebben M, Cerruto MA, De Marco V, Migliorini F, Porcaro AB, Artibani W. Impact of Combination of Local Anesthetic Wounds Infiltration and Ultrasound Transversus Abdominal Plane Block in Patients Undergoing Robot-Assisted Radical Prostatectomy: Perioperative Results of a Double-Blind Randomized Controlled Trial. J Endourol. 2019 Apr;33(4):295-301. doi: 10.1089/end.2018.0761. Epub 2019 Jan 31.

    PMID: 30484332BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kudret Doğru, Prof. Dr.

    TC Erciyes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. (MD)

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 16, 2025

Study Start

May 25, 2025

Primary Completion

December 15, 2025

Study Completion

December 18, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations