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

NCT07826741 | Recruiting

• 1 other identifier: AEŞH-EK-2026-202
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multimodal Analgesia; Pain, Postoperative; Inguinal Hernia Unilateral; Intrathecal Morphine; Transversalis Fascia Plane Block

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 hours after surgery

Secondary Outcomes (4)

• Pain scores

  Up to 24 hours after surgery

• Pain scores

  Up to 24 hours after surgery

• Total Rescue Tramadol Consumption

  Up to 24 hours after surgery

• Side effects

  Up to 24 hours after surgery

Study Arms (3)

Intrathecal Morphine

ACTIVE COMPARATOR

Participants will receive spinal anesthesia with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, with a total intrathecal volume of 3 mL. No additional peripheral nerve block will be performed. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.

Procedure: Intrathecal Morphine Group

Transversalis Fascia Plane Block

ACTIVE COMPARATOR

Participants will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine (3 mL). At the end of surgery, an ultrasound-guided unilateral transversalis fascia plane block will be performed on the surgical side using 30 mL of 0.25% bupivacaine. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.

Procedure: Transversalis Fascia Plane Block Group

Spinal Anesthesia Alone

ACTIVE COMPARATOR

Participants will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine (3 mL) administered intrathecally. No additional neuraxial opioid or regional block will be performed. All participants will receive the standardized postoperative multimodal analgesia protocol and intravenous patient-controlled analgesia.

Procedure: Control Group

Interventions

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.

Intrathecal Morphine

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.

Transversalis Fascia Plane Block

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.

Spinal Anesthesia Alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Musa Zengin, Associate Professor

CONTACT

00905307716235; musazengin@gmail.com

Şule Küreşci Karagöz, Medical Doctor

CONTACT

00905526825835; suleekuresci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 25, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

TU (1)