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NCT Number: NCT07826741

Intrathecal Morphine and Transversalis Fascia Plane Block for Analgesia After Open Inguinal Hernia Repair

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.

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Key information

Conditions

Pain, Postoperative Inguinal Hernia Unilateral Intrathecal Morphine Multimodal Analgesia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Transversalis Fascia Plane Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic and morphine allergy
  • Infection in the intervention area

Treatment and study plan

Intrathecal morphine group

Procedure

Spinal 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

Spinal 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

Spinal 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.

Primary outcomes

  1. Morphine Consumption via Patient-Controlled Analgesia

    Time frame: Up to 24 hours after surgery

    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

  1. Pain scores

    Time frame: Up to 24 hours after surgery

    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.

  2. Pain scores

    Time frame: Up to 24 hours after surgery

    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.

  3. Total Rescue Tramadol Consumption

    Time frame: Up to 24 hours after surgery

    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.

  4. Side effects

    Time frame: Up to 24 hours after surgery

    Side effects, such as allergy , hypotension, nausea/vomiting, and itching, will be recorded.

Study contacts

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

Musa Zengin, Associate Professor

CONTACT

[email protected]

00905307716235

Şule Küreşci Karagöz, Medical Doctor

CONTACT

[email protected]

00905526825835

Sponsors and collaborators

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Other

Registry information

Official study title

Comparison of Intrathecal Morphine, Transversalis Fascia Plane Block, and Spinal Anesthesia Alone for Postoperative Analgesia in Open Inguinal Hernia Repair: A Prospective, Randomized, Assessor-Blinded, Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 21, 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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