Transversalis Fascia Plane Block Versus Low-Dose Intrathecal Morphine for Open Inguinal Hernia Repair

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHitit University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18-80 years

Patients scheduled for elective unilateral open inguinal hernia repair

ASA physical status I-III

Patients planned to undergo spinal anesthesia

Disqualifiers

Refusal to participate

Bilateral inguinal hernia repair

Recurrent inguinal hernia repair

Emergency, incarcerated, or strangulated hernia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal morphine

    Drug

    Patients will receive 100 mcg intrathecal morphine in addition to 15 mg of 0.5% hyperbaric bupivacaine during spinal anesthesia.

  • Ultrasound-guided transversalis fascia plane block

    Procedure/Surgery

    Patients will receive an ultrasound-guided unilateral transversalis fascia plane block on the surgical side using 30 mL of 0.25% bupivacaine before surgery.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intrathecal Morphine GroupActive comparator 1 intervention
Group B: TFP Block GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Rescue Opioid Consumption During the First 24 Postoperative Hours

Total rescue opioid analgesic consumption during the first 24 postoperative hours will be recorded and converted to intravenous morphine equivalents.

Time frame
0-24 hours after surgery

Secondary outcomes

1

Quality of Recovery Score

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
24 hours after surgery
2

Opioid-Related Adverse Effects

Nausea, vomiting, pruritus, urinary retention, sedation, respiratory depression, and oxygen desaturation will be recorded.

Time frame
0-24 hours after surgery

Other outcomes

Sponsors and contacts

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