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).
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.
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 group | Role | What they receive |
|---|---|---|
| TAP Group | Active comparator | Receiving TAP 20 ml bupivacaine 0.25% Receives: Procedure: TAP Plane Block |
| TFP Group | Active comparator | Receiving TFP 20 ml bupivacaine 0.25% Receives: Procedure: TFP Block |
| Control Group | No intervention | Not receiving TAP or TFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 May 2025
- Study start25 May 2025
- Primary completion15 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kudret Dogru, TC Erciyes University
- Investigators
- Kudret Doğru, Prof. Dr., Study director, TC Erciyes University
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 30056612Cacciamani 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT06975735
- Acronym / sponsor ID
- Tapblock / 2025/184
- Conditions
- Pain
- Keywords
- prostatectomy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP Group | Active comparator | Procedure: TAP Plane BlockReceiving TAP 20 ml bupivacaine 0.25% |
| TFP Group | Active comparator | Procedure: TFP BlockReceiving TFP 20 ml bupivacaine 0.25% |
| Control Group | No intervention | –Not receiving TAP or TFP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) Class I or II
- Having regular preoperative visits
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP Plane BlockAlso: TAP BlockThe 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 | Procedure or surgery | TAP Group |
| TFP BlockThe 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 | Procedure or surgery | TFP Group |
Primary outcome
Reducing patient-controlled analgesic consumption
Time frame: From the patient's anesthesia induction in the operating room to the postoperative 24. hours
The time to first analgesic request in the postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 30056612Dal 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.
- Background: PubMed 30484332Cacciamani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kudret Doğru, Prof. Dr. study director
TC Erciyes University
1 site in 1 country: see every site and its status.
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.