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Inguinal Hernia UnilateralTFPB-WINNCT07238829

Transversalis Fascia Plane Block Versus Surgical Wound Infiltration for Postoperative Analgesia in Open Inguinal Hernia Repair

A study testing Ultrasound-Guided Transversalis Fascia Plane Block (TFPB) and Surgical Wound Infiltration in people with Inguinal Hernia Unilateral and Postoperative Pain Management, run by Ondokuz Mayıs University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical trial is to evaluate whether two different analgesic techniques - ultrasound-guided Transversalis Fascia Plane Block (TFPB) and surgical wound infiltration - can improve postoperative pain control in adult patients undergoing open inguinal hernia repair. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ultrasound-Guided Transversalis Fascia Plane Block (TFPB) and Surgical Wound Infiltration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
No sites listed yet
Study dates
1 Jan 2027to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Scheduled for elective unilateral open inguinal hernia repair
  • Planned anesthesia: spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Able to understand the study procedures and provide written informed consent

Who cannot join

  • Body mass index (BMI) > 35 kg/m²
  • Known hypersensitivity to local anesthetics used in the study (e.g., bupivacaine) or to analgesic medications
  • Coagulopathy
  • Infection or hematoma at the planned block site
  • Significant systemic disease (such as chronic kidney disease, hepatic failure, chronic obstructive pulmonary disease, etc.)
  • History of chronic pain or long-term analgesic use
Show all 10Show fewer
  • Inability to use the patient-controlled analgesia system
  • Presence of psychiatric disorders
  • Refusal to participate in the study.
  • Cases with a surgical duration shorter than 30 minutes or longer than 180 minutes were excluded.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

İlke TAMDOGAN, Asst. Prof. contact

+905062916678

drilkeipek@gmail.com

About this study

Official title: Analgesic Efficacy of Ultrasound-Guided Transversalis Fascia Plane Block Versus Surgical Wound Infiltration After Open Inguinal Hernia Surgery: A Randomized Controlled Trial

The purpose of this clinical trial is to evaluate whether two different analgesic techniques - ultrasound-guided Transversalis Fascia Plane Block (TFPB) and surgical wound infiltration - can improve postoperative pain control in adult patients undergoing open inguinal hernia repair.

The key questions that this study aims to answer are:

Read more

Does TFPB reduce total intravenous opioid consumption within the first 24 postoperative hours compared with wound infiltration?

Does TFPB improve postoperative pain scores at rest and during movement compared with wound infiltration?

Does TFPB improve patient satisfaction, reduce the need for rescue analgesics, and enhance overall postoperative recovery quality?

If there is a comparison group:

The investigators will compare the effects of TFPB with wound infiltration to determine whether either technique provides superior postoperative analgesia and reduces opioid requirements.

Participants will be asked to:

Undergo open inguinal hernia repair under spinal anesthesia.

Be randomly assigned to one of two groups:

TFPB Group: Receive an ultrasound-guided transversalis fascia plane block with local anesthetic.

Wound Infiltration Group: Receive local anesthetic infiltration performed by the surgeon along the incision line.

Postoperatively:

Report pain scores at defined intervals.

Receive standardized IV analgesia with documentation of opioid consumption.

Allow assessment of rescue analgesic requirement.

Be monitored for adverse events and recovery outcomes.

Read the detailed description

worldwide. Inadequate analgesia in the early postoperative period may lead to delayed mobilization, prolonged hospital stay, and increased opioid consumption. Accordingly, current international guidelines recommend multimodal analgesia strategies and the use of regional anesthesia techniques when appropriate (1). Surgical wound infiltration is a frequently used component of multimodal analgesia in groin surgery; however, its effectiveness may vary depending on the timing of administration, technique, and the homogeneity of local anesthetic spread, and its duration of action is often limited. Recent clinical series continue to report significant postoperative pain and notable opioid requirements following primary unilateral open repair (1).

In recent years, ultrasound-guided fascial plane blocks have gained increasing attention due to their more predictable spread and potential to provide longer-lasting analgesia (2). The TFPB block is a truncal block achieved by injecting local anesthetic between the transversus abdominis muscle and the transversalis fascia, thereby targeting the T12-L1 spinal nerves. This anatomical distribution provides a strong physiological rationale for its use in inguinal region surgery (3).

Several studies have demonstrated that the TFPB can reduce postoperative pain scores and rescue analgesic requirements in pediatric herniotomy and adult groin surgeries (4). However, randomized controlled trials directly comparing the TFPB with surgical wound infiltration in open inguinal hernia repair remain limited. Existing evidence partly stems from comparisons with other fascial plane blocks (e.g., Quadratus Lumborum [QL], Transversus Abdominis Plane [TAP] block or from studies in different types of groin surgery, such as subinguinal varicocelectomy (5-7). Therefore, whether the TFPB provides a clinically meaningful advantage over wound infiltration in open inguinal hernia repair is a clinically relevant question that remains to be definitively answered.

This study aims to compare the contribution of the TFPB and surgical wound infiltration to postoperative analgesia in patients undergoing elective unilateral open inguinal hernia repair. The primary hypothesis is that TFPB will reduce cumulative rescue opioid consumption during the first 24 postoperative hours compared with wound infiltration. The secondary hypotheses are that TFPB will decrease postoperative pain scores, prolong the time to first rescue analgesia, and improve patient satisfaction without increasing the incidence of postoperative nausea and vomiting (PONV) or other adverse events.

articipants will be randomized into one of two intervention arms.

In the TFPB group, an ultrasound-guided transversalis fascia plane block will be performed in the postoperative period using a standardized volume and concentration of local anesthetic.

In the Wound Infiltration group, local anesthetic will be infiltrated by the surgeon into the relevant layers of the incision site at the end of the surgery.

All patients will receive a standardized spinal anesthesia protocol and a uniform postoperative analgesia regimen. Postoperative pain scores and opioid consumption will be recorded at predefined time intervals. The investigators responsible for postoperative assessments will remain blinded to group allocation throughout the study.

Primary outcome measure:

Total opioid consumption during the first 24 postoperative hours.

Secondary outcome measures:

NRS pain scores at rest and during coughing, the number of patients requiring rescue analgesia, the incidence of postoperative nausea and vomiting, block-related complications, and overall patient satisfaction.

Being tested
Ultrasound-Guided Transversalis Fascia Plane Block (TFPB), Surgical Wound Infiltration
Keywords
transversalis fascia plane block, regional anaesthesia, inguinal hernia, analgesia
Medical subject headings
Hernia, Inguinal, Agnosia

What participants receive

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

  • Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)Procedure or surgery

    An ultrasound-guided Transversalis Fascia Plane Block will be performed by injecting a standardized volume and concentration of local anesthetic between the transversus abdominis muscle and the transversalis fascia. The block will be administered immediately after spinal anesthesia, prior to postoperative transfer. All other perioperative management and postoperative analgesia protocols will be identical to those in the comparison arm.

  • Surgical Wound InfiltrationProcedure or surgery

    At the end of surgery, the operating surgeon will infiltrate a standardized volume and concentration of local anesthetic into the relevant tissue layers of the surgical incision. The infiltration will be performed immediately after skin closure. Participants in this arm will receive the same spinal anesthesia and postoperative analgesia regimen as those in the TFPB group.

Study groups in NCT07238829
Study groupRoleWhat they receive
Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)Active comparatorAn ultrasound-guided Transversalis Fascia Plane Block will be performed by injecting a standardized volume and concentration of local anesthetic between the transversus abdominis muscle and the transversalis fascia. The block will be administered immediately after spinal anesthesia, prior to postoperative transfer. All other perioperative management and postoperative analgesia protocols will be identical to those in the comparison arm.
Receives: Procedure: Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)
Surgical Wound InfiltrationActive comparatorAt the end of surgery, the operating surgeon will infiltrate a standardized volume and concentration of local anesthetic into the relevant tissue layers of the surgical incision. The infiltration will be performed immediately after skin closure. Participants in this arm will receive the same spinal anesthesia and postoperative analgesia regimen as those in the TFPB group.
Receives: Procedure: Surgical Wound Infiltration

What is being measured

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

  1. Total opioid consumption within the first 24 postoperative hours

    Cumulative amount of intravenous rescue opioid (e.g., tramadol or morphine equivalent dose) administered during the first 24 postoperative hours, recorded from the post-anesthesia care unit through postoperative hour 24.

    Measured: 0-24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

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
Parallel groups
Model description
This study employs a parallel-group, randomized controlled design. Participants undergoing elective unilateral open inguinal hernia repair are randomized into one of two intervention arms. In one group, patients receive an ultrasound-guided Transversalis Fascia Plane Block (TFPB), while in the other group, local anesthetic is infiltrated into the surgical incision site. Both interventions are administered in a standardized manner, and all participants receive the same spinal anesthesia protocol and postoperative analgesia regimen. The investigators responsible for postoperative assessments are blinded to group allocation. Postoperative pain scores, opioid consumption, and secondary outcome measures are recorded at predefined time intervals to compare the analgesic effectiveness of the two techniques.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07238829
Sponsor's protocol ID
INGHER2025
Acronym
TFPB-WIN
Status last verified
Jun 2026
First submitted
15 Nov 2025
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: ndividual participant data will not be shared.

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 27067036
  • Celik EC, Ozbey I, Aydin ME, Yayik AM, Oral Ahiskalioglu E, Tor IH, Ahiskalioglu A. Efficacy of transversalis fascia plane block as a novel indication for varicocelectomy surgery: prospective randomized controlled study. BMC Anesthesiol. 2023 Feb 7;23(1):48. doi: 10.1186/s12871-023-02009-z.

    PubMed 36750790
  • Fouad AZ, Abdel-Aal IRM, Gadelrab MRMA, Mohammed HMES. Ultrasound-guided transversalis fascia plane block versus transmuscular quadratus lumborum block for post-operative analgesia in inguinal hernia repair. Korean J Pain. 2021 Apr 1;34(2):201-209. doi: 10.3344/kjp.2021.34.2.201.

    PubMed 33785672
  • Hebbard 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 19495909
  • Tran Q, Boezaart AP, Neal JM. Fascial plane blocks: the next leap. Reg Anesth Pain Med. 2021 Jul;46(7):568-569. doi: 10.1136/rapm-2020-101992. No abstract available.

    PubMed 34145068

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Transversalis Fascia Plane Block (TFPB) and Surgical Wound Infiltration in people with Inguinal Hernia Unilateral and Postoperative Pain Management, run by Ondokuz Mayıs University.

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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact İlke TAMDOGAN, Asst. Prof. (+905062916678, drilkeipek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total opioid consumption within the first 24 postoperative hours (time frame: 0-24 hours after surgery). 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 NCT07238829, 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 25 Jun 2026.

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