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PainTapblockNCT06975735

Does the TAP Block Work Better Than the TFP Block for Relieving Pain

A study testing TAP Plane Block and TFP Block in people with Pain, run by TC Erciyes University at 1 site 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

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. Read more about this study

Who is it for?
Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
TAP Plane Block and TFP Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 May 2025to 18 Dec 2025
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 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.)
  • 1. 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kudret Doğru

    Kayseri, Melikgazi, 38050

Other trials in Turkey (Türkiye)

About this study

Official title: Does the Transversalis Fascia Plane Block Work Better Than the Transversus Abdominis Plane Block for Relieving Pain After a Robotic-assisted Partial Prostatectomy?

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).

Read the detailed description

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 given from the side of the abdomen, have been found to be very useful in surgeries related to women's health, weight loss, and the colon. Research shows that both procedures are ineffective in robot-assisted laparoscopic prostatectomies (RALP).

In this study, doctors will start general anesthesia using propofol and rocuronium as usual and keep it going with a mix of 4-6% desflurane with oxygen, remifentanil, and rocuronium given through an IV.

All procedures will be conducted within the framework of an observational clinical research protocol, and patients will not be subjected to any procedures outside of routine practices.

Before starting the study, patients will be thoroughly informed, and their written consent will be obtained. The study is planned to start in May 2025.

Patients will be examined in the anesthesia outpatient clinic for preoperative evaluation. Demographic data (age, gender, ASA score, height, weight, BMI, and comorbidities) will be recorded in the preoperative patient evaluation form.

Standard monitoring included invasive and non-invasive blood pressure measurements, electrocardiography (ECG), and pulse oximetry. During anesthesia, balanced IV fluid replacement will be provided through a 20-G arterial and three 18-G intravenous cannulas. The patient will be placed in a supine and Trendelenburg surgical position.

This study has been planned as prospective and observational in nature. In this study, patients who undergo robotic-assisted partial prostatectomy at our hospital and will receive a transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block as a standard practice for postoperative pain relief will be followed. Patients who choose not to have these blocks during the pre-surgery information will be placed in the control group and will receive pain relief in the same manner. The control group will include patients who refuse these block applications during preoperative information, and they will receive postoperative analgesia in the same manner.

Which block technique will be applied will be determined entirely by the clinician's decision regarding these cases and the patient's characteristics, and no randomization, intervention, or guidance will be carried out by the researchers.

Groups: 1-Group TFP, 2-Group TAP, 3-Group Control Postoperative analgesic efficacy will be evaluated at 1, 6, and 24 hours. Postoperative pain will be evaluated both at rest and during coughing using a 0-10 point visual analog scale (VAS). As usual, morphine (5 mg i.v.) and paracetamol (1000 mg i.v.) will be provided and recorded as rescue analgesia for pain scores exceeding 3/10 during rest or coughing.

The time of the patients' first standing and walking will be recorded, and the surgeon's satisfaction with postoperative patient comfort will be scored as 1-Excellent, 2-Good, or 3-Poor.

Among the groups, VAS scores, rescue analgesics, postoperative ambulation time, postoperative satisfaction scores (patient and surgeon perspective), and complications such as possible nausea, vomiting, and hypotension will be compared.

The researchers used G Power software to analyze the study's strength before it started, focusing on the average Visual Analog Score in each group, which is the key factor for their main hypothesis. Based on earlier research, they determined that an effect size of 0.35 is important for clinical significance, and using the ANOVA test, they found that they need at least 36 patients in each group, which adds up to 108 patients in total. With this calculation, the power of the study is based on 0.90 and a significance level (α) of 0.05.

The data will be evaluated for normal distribution using the Shapiro-Wilk test and for homogeneity using the Levene test. For normally distributed, homogeneous data, ANOVA and post hoc Tukey tests will be used, while Kruskal-Wallis and chi-square tests will be used for categorical and non-normally distributed data. When necessary, the Bonferroni correction will be applied. For multiple comparisons, those with a p-value < 0.05 will be considered statistically significant. All statistical analyses will be conducted using JAMOVI version 2.6.19 for Windows.

Conditions
Pain
Being tested
TAP Plane Block, TFP Block
Keywords
prostatectomy, pain
Medical subject headings
Pain

What participants receive

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

  • TAP Plane BlockProcedure or surgery

    Also called TAP Block

    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

  • TFP BlockProcedure or surgery

    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

Study groups in NCT06975735
Study groupRoleWhat they receive
TAP GroupActive comparatorReceiving TAP 20 ml bupivacaine 0.25%
Receives: Procedure: TAP Plane Block
TFP GroupActive comparatorReceiving TFP 20 ml bupivacaine 0.25%
Receives: Procedure: TFP Block
Control GroupNo interventionNot receiving TAP or TFP

What is being measured

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

  1. Reducing patient-controlled analgesic consumption

    The time to first analgesic request in the postoperative period

    Measured: From the patient's anesthesia induction in the operating room to the postoperative 24. 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 May 2025
  2. Study start25 May 2025
  3. Primary completion15 Dec 2025
  4. Study completion18 Dec 2025

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975735
Sponsor's protocol ID
2025/184
Acronym
Tapblock
Status last verified
Dec 2025
First submitted
9 May 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30056612
  • 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.

    PubMed 30484332

Questions about this trial

What is this clinical trial studying?

A study testing TAP Plane Block and TFP Block in people with Pain, run by TC Erciyes University at 1 site 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 2 inclusion and 5 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Reducing patient-controlled analgesic consumption (time frame: From the patient's anesthesia induction in the operating room to the postoperative 24. 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 NCT06975735, which also lists 2 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 24 Dec 2025.

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Tapblock Clinical Trial NCT06975735 | AzTrials