About this trial
Inguinal hernia is a common surgical condition, and open inguinal hernia repair may be associated with significant postoperative pain. Inadequate pain control can delay early mobilization, reduce patient comfort, and increase the need for opioid analgesics. Therefore, effective postoperative pain management is an important component of perioperative care.
Several analgesic strategies can be used after open inguinal hernia repair, including systemic multimodal analgesia, neuraxial opioids, and regional anesthesia techniques. Intrathecal morphine can provide prolonged postoperative analgesia but may be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. Ultrasound-guided transversalis fascia plane block is a regional anesthesia technique designed to provide analgesia to the inguinal region while potentially reducing systemic opioid requirements.
The aim of this prospective, randomized, assessor-blinded, controlled trial is to compare the postoperative analgesic efficacy of intrathecal morphine, transversalis fascia plane block, and spinal anesthesia alone in adult patients undergoing elective open unilateral inguinal hernia repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years
American Society of Anesthesiologists physical status I-II-III
Body mass index between 18 and 30 kg/m²
Patients undergoing elective open inguinal hernia repair
Disqualifiers
Patient refusing the procedure
History of chronic analgesic or opioid therapy
History of local anesthetic and morphine allergy
Infection in the intervention area
Trial design
Parallel
Treatments tested in this trial
Intrathecal Morphine Group
Procedure/SurgerySpinal anesthesia will be performed using 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, prepared to a total intrathecal volume of 3 mL. No additional peripheral regional block will be performed in this group. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.
Transversalis Fascia Plane Block Group
Procedure/SurgerySpinal anesthesia will be performed with 15 mg of 0.5% hyperbaric bupivacaine (3 mL). At the completion of surgery, an ultrasound-guided unilateral transversalis fascia plane block will be performed on the surgical side. A 22-gauge, 80-100 mm block needle will be advanced using an in-plane technique to the transversalis fascial plane, and 30 mL of 0.25% bupivacaine will be injected after negative aspiration. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.
Control Group
Procedure/SurgerySpinal anesthesia will be performed using 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, prepared to a total intrathecal volume of 3 mL. No additional peripheral regional block will be performed in this group. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.
Treatment groups
Trial outcomes
Primary outcomes
Morphine Consumption via Patient-Controlled Analgesia
The total amount of intravenous morphine administered via patient-controlled analgesia during the first 24 postoperative hours will be recorded in milligrams (mg) based on the PCA device records.
Secondary outcomes
Pain scores
Pain will be assessed at rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 4th, 8th, 12th, and 24th hours after surgery.
Pain scores
Pain will be assessed while coughing using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 4th, 8th, 12th, and 24th hours after surgery.
Total Rescue Tramadol Consumption
The total amount of intravenous tramadol administered as rescue analgesia during the first 24 postoperative hours will be recorded in milligrams (mg). Intravenous tramadol will be administered when the Visual Analog Scale (VAS) pain score is greater than 40 mm.
Side effects
Side effects, such as allergy , hypotension, nausea/vomiting, and itching, will be recorded.
Sponsors and contacts
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Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution