Does the TAP Block Work Better Than the TFP Block for Relieving Pain
NCT ID: NCT06975735
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
108 participants
INTERVENTIONAL
2025-05-25
2025-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TAP Group
Receiving TAP 20 ml bupivacaine 0.25%
TAP Plane 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 Group
Receiving TFP 20 ml bupivacaine 0.25%
TFP Block
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
Control Group
Not receiving TAP or TFP
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAP Plane 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 Block
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Having regular preoperative visits
Exclusion Criteria
2. Patients with coagulopathy
3. Those with a history of allergies
4. 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
18 Years
70 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TC Erciyes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kudret Dogru
Prof. Dr. (MD)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kudret Doğru, Prof. Dr.
Role: STUDY_DIRECTOR
TC Erciyes University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kudret Doğru
Kayseri, Melikgazi, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025/184
Identifier Type: -
Identifier Source: org_study_id