Laparoscopic Inguinal Hernia RepairTFPBNCT06778629
Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair
A study testing Transversalis Fascia Plane Block, Post Operative Pain Management and Port Site Infiltration in people with Laparoscopic Inguinal Hernia Repair and Acute Post Operative Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Inguinal Hernia Repair, Acute Post Operative Pain
- What is being tested?
- Transversalis Fascia Plane Block, Post Operative Pain Management and Port Site Infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2025to 20 Jul 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I- II Patients
- Unilateral Inguinal Hernia Repair Surgery
- Elective Operations
Who cannot join
- Patients with a history of chronic pain
- Evidence of infection in the intervention area
- Allergy to local anesthetics
- Coagulopathy
- Body-mass index (BMI) ≥ 30
- Body weight ≤ 50 kg
- Patients who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Mega Hospital Complex
Istanbul, Bagcilar, 34212
About this study
Official title: Evaluation of the Effectiveness of Transversalis Fascia Plane Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair
Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair.
This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.
Read the detailed description
Inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. Even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications, postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.
Transversalis Fascia Plane Block (TFPB) is a body block that blocks the T12-L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall Its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair.
This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.
- Being tested
- Transversalis Fascia Plane Block, Post Operative Pain Management, Port Site Infiltration
- Keywords
- Transversalis Fascia Plane Block, Acute Postoperative Pain, Laparoscopic Inguinal Hernia Repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascia Plane BlockProcedure or surgery
After the wound closure is completed and the patient is still under general anesthesia the TFPB will be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed longitudinally, 2-3 cm laterally, just above the iliac crest at the mid-axillary line. After the external oblique, internal oblique, and transversus abdominis muscles are distinguished, the common aponeurosis of the transversus abdominis and the internal oblique muscle will be found. The block needle will be directed from anterior to posterior, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine, Polifarma ®) will be applied between the transversus abdominis muscle and transversalis fascia.
Post Operative Pain ManagementProcedure or surgery
Acetaminophen 1 gr (Paracerol, Polifarma®) intravenous (IV), and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be administered to all patients 30 minutes before wound closure. After surgery, Acetaminophen (Paracerol, Polifarma®) 1 gr IV, and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be given three times a day. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV pethidine (Aldolan, Liba Laboratory ®) 0,5 mg/kg will be given as a rescue analgesic.
Port Site InfiltrationProcedure or surgery
A total of 20 ml of 0.25% bupivacaine ( (Buvicaine, Polifarma ®) will be applied to the trocar entry points by the surgeon at the beginning of the operation, before entering the trocars.
| Study group | Role | What they receive |
|---|---|---|
| Group T = TFPB group | Experimental | Transversalis Fascia Plane block will be performed. Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. Receives: Procedure: Transversalis Fascia Plane Block; Procedure: Post Operative Pain Management; Procedure: Port Site Infiltration |
| Group K = Control group | Active comparator | Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. No plane block will be applied. Receives: Procedure: Post Operative Pain Management; Procedure: Port Site Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue analgesic use
The primary aim is to compare the rescue analgesia amount and its time used in the postoperative 24-hour period
Measured: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.
Secondary outcomes (2)
Compare postoperative pain scores (NRS scores)
The secondary aim is to compare the pain scores at rest and with movement. Postoperative pain assessment will be performed using the Numerical Rating Scale (NRS) (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded. Low NRS is associated with better pain control.
Measured: NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.
Side effects and complications
To evaluate block-related complications and side effects (allergic reaction, nausea, vomiting)- block or opioid related
Measured: Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start14 Feb 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Inguinal Hernia RepairStudies 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
- Parallel groups
- Model description
- Sixty patients aged 18-65 with American Society of Anesthesiologists (ASA) classification I-II scheduled for laparoscopic inguinal hernia repair operation will be included in the study. Before entering the operating room, patients will be randomly divided into two groups (Group T = TFPB group, Group K = control group), each with 30 patients.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ince, Istanbul Medipol University Hospital
- Investigators
- BAHADIR CIFTCI, Study chair, ISTANBUL MUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778629
- Sponsor's protocol ID
- Medipol Hospital 5
- Acronym
- TFPB
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data (IPD).
Publications
Celik HK, Tulgar S, Buk OF, Koc K, Unal M, Genc C, Suren M. Comparison of the analgesic efficacy of the ultrasound-guided transversalis fascia plane block and erector spinae plane block in patients undergoing open inguinal hernia repair under spinal anesthesia. Korean J Anesthesiol. 2024 Apr;77(2):255-264. doi: 10.4097/kja.23404. Epub 2024 Jan 8.
PubMed 38185619Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.
PubMed 39039833Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
PubMed 19495909Xu LS, Li Q, Wang Y, Wang JW, Wang S, Wu CW, Cao TT, Xia YB, Huang XX, Xu L. Current status and progress of laparoscopic inguinal hernia repair: A review. Medicine (Baltimore). 2023 Aug 4;102(31):e34554. doi: 10.1097/MD.0000000000034554.
PubMed 37543778Tolver MA, Rosenberg J, Bisgaard T. Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review. Acta Anaesthesiol Scand. 2012 May;56(5):549-57. doi: 10.1111/j.1399-6576.2011.02633.x. Epub 2012 Jan 19.
PubMed 22260427
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Transversalis Fascia Plane Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06778629
- Acronym / sponsor ID
- TFPB / Medipol Hospital 5
- Keywords
- Transversalis Fascia Plane Block, Acute Postoperative Pain, Laparoscopic Inguinal Hernia Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 16 Jan 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.
Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair.
This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.
Detailed description
Inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. Even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications, postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.
Transversalis Fascia Plane Block (TFPB) is a body block that blocks the T12-L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall Its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair.
This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty patients aged 18-65 with American Society of Anesthesiologists (ASA) classification I-II scheduled for laparoscopic inguinal hernia repair operation will be included in the study. Before entering the operating room, patients will be randomly divided into two groups (Group T = TFPB group, Group K = control group), each with 30 patients.
| Arm | Type | Receives |
|---|---|---|
| Group T = TFPB group | Experimental | Procedure: Transversalis Fascia Plane Block, Procedure: Post Operative Pain Management, Procedure: Port Site InfiltrationTransversalis Fascia Plane block will be performed. Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. |
| Group K = Control group | Active comparator | Procedure: Post Operative Pain Management, Procedure: Port Site InfiltrationLocal anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. No plane block will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) classification I- II Patients
- Unilateral Inguinal Hernia Repair Surgery
- Elective Operations
Key exclusion criteria (7 listed)
- Patients with a history of chronic pain
- Evidence of infection in the intervention area
- Allergy to local anesthetics
- Coagulopathy
- Body-mass index (BMI) ≥ 30
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 |
|---|---|---|
| Transversalis Fascia Plane BlockAfter the wound closure is completed and the patient is still under general anesthesia the TFPB will be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed longitudinally, 2-3 cm laterally, just above the iliac crest at the mid-axillary line. After the external oblique, internal oblique, and transversus abdominis muscles are distinguished, the common aponeurosis of the transversus abdominis and the internal oblique muscle will be found. The block needle will be directed from anterior to posterior, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine, Polifarma ®) will be applied between the transversus abdominis muscle and transversalis fascia. | Procedure or surgery | Group T = TFPB group |
| Post Operative Pain ManagementAcetaminophen 1 gr (Paracerol, Polifarma®) intravenous (IV), and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be administered to all patients 30 minutes before wound closure. After surgery, Acetaminophen (Paracerol, Polifarma®) 1 gr IV, and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be given three times a day. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV pethidine (Aldolan, Liba Laboratory ®) 0,5 mg/kg will be given as a rescue analgesic. | Procedure or surgery | Group K = Control group, Group T = TFPB group |
| Port Site InfiltrationA total of 20 ml of 0.25% bupivacaine ( (Buvicaine, Polifarma ®) will be applied to the trocar entry points by the surgeon at the beginning of the operation, before entering the trocars. | Procedure or surgery | Group K = Control group, Group T = TFPB group |
Primary outcome
Rescue analgesic use
Time frame: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.
The primary aim is to compare the rescue analgesia amount and its time used in the postoperative 24-hour period
2 secondary outcomes
Compare postoperative pain scores (NRS scores)
Time frame: NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.
Side effects and complications
Time frame: Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively
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 11 Aug 2026.
- Results publication: PubMed 38185619Celik HK, Tulgar S, Buk OF, Koc K, Unal M, Genc C, Suren M. Comparison of the analgesic efficacy of the ultrasound-guided transversalis fascia plane block and erector spinae plane block in patients undergoing open inguinal hernia repair under spinal anesthesia. Korean J Anesthesiol. 2024 Apr;77(2):255-264. doi: 10.4097/kja.23404. Epub 2024 Jan 8.
- Results publication: PubMed 39039833Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.
- Results publication: PubMed 19495909Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
- Results publication: PubMed 37543778Xu LS, Li Q, Wang Y, Wang JW, Wang S, Wu CW, Cao TT, Xia YB, Huang XX, Xu L. Current status and progress of laparoscopic inguinal hernia repair: A review. Medicine (Baltimore). 2023 Aug 4;102(31):e34554. doi: 10.1097/MD.0000000000034554.
- Results publication: PubMed 22260427Tolver MA, Rosenberg J, Bisgaard T. Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review. Acta Anaesthesiol Scand. 2012 May;56(5):549-57. doi: 10.1111/j.1399-6576.2011.02633.x. Epub 2012 Jan 19.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data (IPD).
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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.
BAHADIR CIFTCI study chair
ISTANBUL MUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversalis Fascia Plane Block, Post Operative Pain Management and Port Site Infiltration in people with Laparoscopic Inguinal Hernia Repair and Acute Post Operative Pain, run by Istanbul Medipol University Hospital 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 3 inclusion and 7 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 11 Aug 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?
Rescue analgesic use (time frame: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.). 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 NCT06778629, which also lists 5 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 11 Aug 2026.