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Not Yet Recruiting NCT07238829

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

Conditions: Inguinal Hernia Unilateral, Postoperative Pain Management, Regional Anaesthesia, Transversalis Fascia Plane Block

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 104
Sponsor: Ondokuz Mayıs University

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07238829). StuddyBuddy aggregates publicly available trial information.