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

NCT07238829 | Not Yet Recruiting

• 1 other identifier: INGHER2025
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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. The key questions that this study aims to answer are: 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.

Conditions

Inguinal Hernia Unilateral; Postoperative Pain Management; Regional Anaesthesia; Transversalis Fascia Plane Block

Keywords

transversalis fascia plane block; regional anaesthesia; inguinal hernia; analgesia

Outcome Measures

Primary Outcomes (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.

  0-24 hours after surgery

Study Arms (2)

Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)

Surgical Wound Infiltration

ACTIVE COMPARATOR

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.

Procedure: Surgical Wound Infiltration

Interventions

Ultrasound-Guided Transversalis Fascia Plane Block (TFPB) PROCEDURE

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.

Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)

Surgical Wound Infiltration PROCEDURE

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.

Surgical Wound Infiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• Giresun Training and Research Hospital: collaborator

Related Publications (5)

• 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.

  PMID: 27067036 RESULT

• 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.

  PMID: 36750790 RESULT

• 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.

  PMID: 33785672 RESULT

• 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.

  PMID: 19495909 RESULT

• 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.

  PMID: 34145068 RESULT

MeSH Terms

Conditions

Hernia, Inguinal; Agnosia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• İlke TAMDOGAN, Asst. Prof.

  Giresun University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İlke TAMDOGAN, Asst. Prof.

CONTACT

+905062916678; drilkeipek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share