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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOndokuz Mayıs University

About this 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:

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Scheduled for elective unilateral open inguinal hernia repair

Planned anesthesia: spinal anesthesia

American Society of Anesthesiologists (ASA) physical status I-II

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)

    Procedure/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 Infiltration

    Procedure/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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)Active comparator 1 intervention
Group B: Surgical Wound InfiltrationActive comparator 1 intervention

Trial outcomes

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.

Time frame
0-24 hours after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ondokuz Mayıs University

Lead sponsor

Giresun University

Sponsor institution

Giresun Training and Research Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: