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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ultrasound-Guided Transversalis Fascia Plane Block (TFPB)
Procedure/SurgeryAn 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/SurgeryAt 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
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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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: