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

NCT07695935 | Recruiting

• 1 other identifier: 2026-32
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Postoperative analgesia; Transversalis fascia plane block; Opioid consumption; Regional anesthesia; Intrathecal morphine

Outcome Measures

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.

  0-24 hours after surgery

Secondary Outcomes (2)

• Quality of Recovery Score

  24 hours after surgery

• Opioid-Related Adverse Effects

  0-24 hours after surgery

Study Arms (2)

Intrathecal Morphine Group

ACTIVE COMPARATOR

Patients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine plus 100 mcg intrathecal morphine. No TFP block will be performed.

Drug: Intrathecal morphine

TFP Block Group

EXPERIMENTAL

An ultrasound-guided unilateral transversalis fascia plane block will be performed using 30 mL of 0.25% bupivacaine on the surgical side before open inguinal hernia repair. The local anesthetic dose will be adjusted according to patient weight and maximum safe dose limits.

Procedure: Ultrasound-guided transversalis fascia plane block

Interventions

Intrathecal morphine DRUG

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

Intrathecal Morphine Group

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.

TFP Block Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit university

Çorum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sibel Onen Ozdemir, MD

CONTACT

+905442892194; sibelonen89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor who records postoperative pain scores, rescue analgesic consumption, opioid-related adverse effects, quality of recovery, and follow-up outcomes will be blinded to group allocation. The anesthesiologist performing spinal anesthesia or the TFP block cannot be blinded because of the nature of the interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

TU (1)