Hysterectomy, Benign Uterine DiseasesNCT06853782
Comparison of Postoperative Analgesic Efficacy of TAP Block and TFP Block in Patients Undergoing Abdominal Hysterectomy
A study testing High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA) in people with Hysterectomy, Benign Uterine Diseases and Abdominal Pain (AP), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Total abdominal hysterectomy is one of the most commonly performed surgeries in women and is known to cause significant pain in especially early postoperative period. The goal of this clinical trial is to compare analgesic efficiacy of TAP block, which is well established by studies in hysterectomy surgeries, and TFP… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy, Benign Uterine Diseases, Abdominal Pain (AP)
- What is being tested?
- High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 18 Sep 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA scores of 1-2
- Adults aged 18+ years
- Diagnosed with benign uterine neoplasms and will undergo elective total abdominal hysterectomy via Pfannenstiel incision under general anesthesia
- Agreed to participate in the study will be included.
Who cannot join
- Patients with known
- Neuropathy
- Renal failure
- Hepatic failure
- Coagulopathy
- Skin infection at the site of intervention
Show all 13Show fewer
- Allergy to local anesthetics
- BMI > 35 kg/m²
- Hysterectomy surgery extended due to malignancy or multiple surgeries during the same hospitalization
- Emergency surgeries
- ASA scores of 3-4
- Emergency surgery
- Patients who do not consent to participate in the study will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Hospital
Ankara, Turkey, 06230
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block and Transversalis Fascia Plane (TFP) Block in Patients Undergoing Elective Total Abdominal Hysterectomy
Total abdominal hysterectomy is one of the most commonly performed surgeries in women and is known to cause significant pain in especially early postoperative period. The goal of this clinical trial is to compare analgesic efficiacy of TAP block, which is well established by studies in hysterectomy surgeries, and TFP block, a relatively new block with good analgesic effect when used for lower abdominal surgeries, in patients undergoing abdominal hysterectomy surgery.The main parameters to compare the analgesic efficiacy of TAP and TFP blocks are;
- Pain scores in motion
- Opioid consumption
Read more
Researchers will apply the lateral TAP block and TFP block, prepare the postoperative analgesic treatment regimen and record the patients' analgesic consumption, make ward visits and ask patients about their pain intensity and check for opioid consumption and associated side effects, block-related complications, mobilization, length of hospital stay, and patient satisfaction in patients undergoing elective total abdominal hysterectomy surgery.
Participants will score the pain they feel in motion with certain pain scales.Participants will also respond to the researchers' questions for other parameters in study.
Read the detailed description
Total abdominal hysterectomy is a commonly performed surgical procedure in women that involves the surgical removal of the uterus and is known to cause significant pain, especially during the early postoperative period.
This study aims to prospectively compare the effects of lateral TAP block and TFP block in patients undergoing elective total abdominal hysterectomy with Pfannenstiel incision under general anesthesia for benign uterine neoplasms in a randomized controlled manner.
The TAP block is a fascial plane block targeting the trunkal T6-T12/L1 nerves located between the internal oblique and transversus abdominis muscles and is an effective regional anesthesia method for abdominal surgeries. In patients undergoing total abdominal hysterectomy, TAP block significantly reduces opioid consumption during the postoperative period and results in marked decreases in pain scores at rest and during movement without causing side effects.
The TFP block is a regional analgesia method used in lower abdominal surgeries targeting the branches of the trunkal T12-L1 nerves, located between the transversus abdominis muscle and transversalis fascia. While the TAP block covers dermatomes from T6-L1, the TFP block targets dermatomes T12-L1. A significant difference from the TAP block is that the TFP block provides effective analgesia in areas innervated by the lateral cutaneous branches emerging from the L1 dermatome that TAP block may not fully cover.
- Being tested
- High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)
- Keywords
- Transversus Abdominis Plane Block, Transversalis Fascia Plane Block, Total Abdominal Hysterectomy, Postoperative Analgesia, Ultrasound
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)Device
A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups.
High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)Device
A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Group | Active comparator | In the TAP block group, the lateral transversus abdominis plane block will be performed by the anesthesiologist under ultrasound guidance using a linear probe after the completion of the surgery. Patients will receive 40 ml of 0.25% bupivacaine, administered in two equal doses, into the fascial plane between the internal oblique muscle and the transversus abdominis muscle on both sides. Receives: Device: High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA) |
| TFP Block Group | Active comparator | In the TFP block group, the transversalis fascia plane block will be performed by the anesthesiologist under ultrasound guidance using a linear probe after the completion of the surgery. Patients will receive 40 ml of 0.25% bupivacaine, administered in two equal doses, between transversus abdominis muscle and transversalis fascia on both sides. Receives: Device: High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Postoperative pain assessment will be performed by a researcher at 30th minutes,1st, 2nd, 12th and 24th hours after the block, using the Numerical Rating Scale (NRS) for pain in movement. Patients will be blinded to the groups they participate in and asked to rate their pain on a scale from 0 to 10, where 0 means no pain and 10 represents the worst pain they can imagine.
Measured: Postoperative 30th minute, 1st, 2nd, 12th and 24th hours
Secondary outcomes (6)
Tramadol Consumption
Tramadol consumption (between 0-6, 6-12, 12-24 hours) will be assessed by a patient controlled analgesia (PCA) device.
Additionally, in patients receiving rescue tramadol, the amount of tramadol required will be evaluated by reviewing the patient's daily medication order records.
Measured: Postoperative 0-6th, 6-12th, 12-24th hours
Rescue Tramadol Need
The need for rescue tramadol (Present/Absent), will be assessed by reviewing the patient's daily medication order records.
Measured: Postoperative 0-24th hours
Adverse Reactions
Opioid associated side effects such as nausea, vomiting, constipation, pruritis, urinary retention, respiratory depression and block related complications will be assessed.
Measured: Postoperative 24th hour
Patient Satisfaction
Patient satisfaction will be assessed by asking patients to choose one of the following options regarding their postoperative comfort: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied.
Measured: Postoperative 24th hour
Early Mobilization
Early mobilization will be assessed based on whether the patient started to walk within the first 24 hours postoperatively.
Measured: Postoperative 24th hour
Duration of Postoperative Hospital Stay
The duration of the postoperative hospital stay will be assessed by checking the operation day and discharge day in the hospital records.
Measured: Postoperative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 Jul 2023
- Primary completion12 Sep 2023
- Study completion18 Sep 2023
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 Hysterectomy, Benign Uterine DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BENSU KARAKOYAK YAĞCI, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853782
- Sponsor's protocol ID
- KA-22062
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Via mail
Publications
Lopez-Gonzalez JM, Lopez-Alvarez S, Jimenez Gomez BM, Arean Gonzalez I, Illodo Miramontes G, Padin Barreiro L. Ultrasound-guided transversalis fascia plane block versus anterior transversus abdominis plane block in outpatient inguinal hernia repair. Rev Esp Anestesiol Reanim. 2016 Nov;63(9):498-504. doi: 10.1016/j.redar.2016.02.005. Epub 2016 Apr 8. English, Spanish.
PubMed 27067036Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
PubMed 19020158
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block and Transversalis Fascia Plane (TFP) Block in Patients Undergoing Elective Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT06853782
- Acronym / sponsor ID
- KA-22062
- Keywords
- Transversus Abdominis Plane Block, Transversalis Fascia Plane Block, Total Abdominal Hysterectomy, Postoperative Analgesia, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 3 Mar 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.
Total abdominal hysterectomy is one of the most commonly performed surgeries in women and is known to cause significant pain in especially early postoperative period. The goal of this clinical trial is to compare analgesic efficiacy of TAP block, which is well established by studies in hysterectomy surgeries, and TFP block, a relatively new block with good analgesic effect when used for lower abdominal surgeries, in patients undergoing abdominal hysterectomy surgery.The main parameters to compare the analgesic efficiacy of TAP and TFP blocks are;
- Pain scores in motion
- Opioid consumption
Researchers will apply the lateral TAP block and TFP block, prepare the postoperative analgesic treatment regimen and record the patients' analgesic consumption, make ward visits and ask patients about their pain intensity and check for opioid consumption and associated side effects, block-related complications, mobilization, length of hospital stay, and patient satisfaction in patients undergoing elective total abdominal hysterectomy surgery.
Participants will score the pain they feel in motion with certain pain scales.Participants will also respond to the researchers' questions for other parameters in study.
Detailed description
Total abdominal hysterectomy is a commonly performed surgical procedure in women that involves the surgical removal of the uterus and is known to cause significant pain, especially during the early postoperative period.
This study aims to prospectively compare the effects of lateral TAP block and TFP block in patients undergoing elective total abdominal hysterectomy with Pfannenstiel incision under general anesthesia for benign uterine neoplasms in a randomized controlled manner.
The TAP block is a fascial plane block targeting the trunkal T6-T12/L1 nerves located between the internal oblique and transversus abdominis muscles and is an effective regional anesthesia method for abdominal surgeries. In patients undergoing total abdominal hysterectomy, TAP block significantly reduces opioid consumption during the postoperative period and results in marked decreases in pain scores at rest and during movement without causing side effects.
The TFP block is a regional analgesia method used in lower abdominal surgeries targeting the branches of the trunkal T12-L1 nerves, located between the transversus abdominis muscle and transversalis fascia. While the TAP block covers dermatomes from T6-L1, the TFP block targets dermatomes T12-L1. A significant difference from the TAP block is that the TFP block provides effective analgesia in areas innervated by the lateral cutaneous branches emerging from the L1 dermatome that TAP block may not fully cover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block Group | Active comparator | Device: High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)In the TAP block group, the lateral transversus abdominis plane block will be performed by the anesthesiologist under ultrasound guidance using a linear probe after the completion of the surgery. Patients will receive 40 ml of 0.25% bupivacaine, administered in two equal doses, into the fascial plane between the internal oblique muscle and the transversus abdominis muscle on both sides. |
| TFP Block Group | Active comparator | Device: High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)In the TFP block group, the transversalis fascia plane block will be performed by the anesthesiologist under ultrasound guidance using a linear probe after the completion of the surgery. Patients will receive 40 ml of 0.25% bupivacaine, administered in two equal doses, between transversus abdominis muscle and transversalis fascia on both sides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA scores of 1-2
- Adults aged 18+ years
- Diagnosed with benign uterine neoplasms and will undergo elective total abdominal hysterectomy via Pfannenstiel incision under general anesthesia
- Agreed to participate in the study will be included.
Key exclusion criteria (13 listed)
- Patients with known
- Skin infection at the site of intervention
- Allergy to local anesthetics
- BMI > 35 kg/m²
- Hysterectomy surgery extended due to malignancy or multiple surgeries during the same hospitalization
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 |
|---|---|---|
| High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups. | Device | TAP Block Group |
| High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups. | Device | TFP Block Group |
Primary outcome
Numeric Rating Scale
Time frame: Postoperative 30th minute, 1st, 2nd, 12th and 24th hours
Postoperative pain assessment will be performed by a researcher at 30th minutes,1st, 2nd, 12th and 24th hours after the block, using the Numerical Rating Scale (NRS) for pain in movement. Patients will be blinded to the groups they participate in and asked to rate their pain on a scale from 0 to 10, where 0 means no pain and 10 represents the worst pain they can imagine.
6 secondary outcomes
Tramadol Consumption
Time frame: Postoperative 0-6th, 6-12th, 12-24th hours
Rescue Tramadol Need
Time frame: Postoperative 0-24th hours
Adverse Reactions
Time frame: Postoperative 24th hour
Patient Satisfaction
Time frame: Postoperative 24th hour
Early Mobilization
Time frame: Postoperative 24th hour
Duration of Postoperative Hospital Stay
Time frame: Postoperative 7th day
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 6 Jan 2026.
- Background: PubMed 27067036Lopez-Gonzalez JM, Lopez-Alvarez S, Jimenez Gomez BM, Arean Gonzalez I, Illodo Miramontes G, Padin Barreiro L. Ultrasound-guided transversalis fascia plane block versus anterior transversus abdominis plane block in outpatient inguinal hernia repair. Rev Esp Anestesiol Reanim. 2016 Nov;63(9):498-504. doi: 10.1016/j.redar.2016.02.005. Epub 2016 Apr 8. English, Spanish.
- Background: PubMed 19020158Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Individual participant dataSharing planned: No. Via mail
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA) in people with Hysterectomy, Benign Uterine Diseases and Abdominal Pain (AP), run by Hacettepe 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 4 inclusion and 13 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 6 Jan 2026. 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?
Numeric Rating Scale (time frame: Postoperative 30th minute, 1st, 2nd, 12th and 24th 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 NCT06853782, 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 6 Jan 2026.