Hitit university
Çorum, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ozgur Yagan, Professor
CONTACT
NCT Number: NCT07695935
Open inguinal hernia repair is commonly associated with early postoperative pain, which may delay mobilization, reduce patient satisfaction, and increase opioid consumption. Low-dose intrathecal morphine may provide prolonged postoperative analgesia after spinal anesthesia; however, it may also be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, sedation, and respiratory depression.
The transversalis fascia plane block is an ultrasound-guided fascial plane block that targets the sensory innervation of the lower abdominal wall, particularly the T12-L1 dermatomal region and the ilioinguinal and iliohypogastric nerve distribution. Although TFP block has been evaluated in lower abdominal procedures, direct comparison with low-dose intrathecal morphine in open inguinal hernia repair is limited.
This prospective, randomized, controlled, assessor-blinded trial aims to compare ultrasound-guided TFP block with low-dose intrathecal morphine in adult patients undergoing elective unilateral open inguinal hernia repair under spinal anesthesia. The primary outcome is total rescue opioid consumption during the first 24 postoperative hours. Secondary outcomes include pain scores at rest and with movement, time to first rescue analgesia, opioid-related adverse effects, quality of recovery, patient satisfaction, mobilization time, readiness for discharge, block success, sensory block distribution, and block-related complications.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Çorum, Turkey (Türkiye)
Location status: Recruiting
Ozgur Yagan, Professor
CONTACT
Adult patients scheduled for elective unilateral open inguinal hernia repair under spinal anesthesia will be enrolled. After written informed consent, eligible patients will be randomly assigned in a 1:1 ratio to one of two groups.
In the intrathecal morphine group, patients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine plus 100 mcg intrathecal morphine. No TFP block will be performed in this group.
In the TFP block group, patients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine without intrathecal morphine. In addition, an ultrasound-guided unilateral TFP block will be performed on the surgical side before surgery using 30 mL of 0.25% bupivacaine, within the maximum safe dose limits.
All patients will receive a standardized multimodal postoperative analgesia protocol. Pain scores, rescue analgesic consumption, opioid-related adverse effects, quality of recovery, and safety outcomes will be recorded during the first 24 postoperative hours. Persistent or chronic postoperative inguinal pain may be evaluated exploratorily during follow-up if sufficient data are available.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive 100 mcg intrathecal morphine in addition to 15 mg of 0.5% hyperbaric bupivacaine during spinal anesthesia.
Patients will receive an ultrasound-guided unilateral transversalis fascia plane block on the surgical side using 30 mL of 0.25% bupivacaine before surgery.
Time frame: 0-24 hours after surgery
Total rescue opioid analgesic consumption during the first 24 postoperative hours will be recorded and converted to intravenous morphine equivalents.
Time frame: 24 hours after surgery
Quality of recovery will be assessed using the QoR-15 score. The total score ranges from 0 to 150, with higher scores indicating better recovery.
Time frame: 0-24 hours after surgery
Nausea, vomiting, pruritus, urinary retention, sedation, respiratory depression, and oxygen desaturation will be recorded.
Contact information is provided by the study sponsor or research team.
Hitit University
Other
Comparison of Ultrasound-Guided Transversalis Fascia Plane Block and Low-Dose Intrathecal Morphine for Postoperative Analgesia After Open Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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