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NCT Number: NCT07695935

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hitit university

Çorum, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ozgur Yagan, Professor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients able to understand and report postoperative pain scores
  • Patients who provide written informed consent

Exclusion criteria

  • Refusal to participate
  • Bilateral inguinal hernia repair
  • Recurrent inguinal hernia repair
  • Emergency, incarcerated, or strangulated hernia
  • Need for general anesthesia
  • Contraindication to spinal anesthesia
  • Coagulopathy or anticoagulant use contraindicating neuraxial or peripheral block
  • Infection at the injection site
  • Known allergy to local anesthetics, morphine, or study medications
  • Chronic opioid use
  • Preoperative chronic groin pain or neuropathic pain history
  • Severe hepatic or renal failure
  • Neurological or psychiatric condition preventing communication or pain assessment
  • Expected inability to complete postoperative follow-up

Treatment and study plan

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

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

Primary outcomes

  1. Total Rescue Opioid Consumption During the First 24 Postoperative Hours

    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.

Secondary outcomes

  1. Quality of Recovery Score

    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.

  2. Opioid-Related Adverse Effects

    Time frame: 0-24 hours after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sibel Onen Ozdemir, MD

CONTACT

[email protected]

+905442892194

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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