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

July 6, 2026 updated by: Sibel Onen Ozdemir, Hitit University

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Çorum, Turkey (Türkiye)
        • Recruiting
        • Hitit university
        • Contact:
          • Ozgur Yagan, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Patients will receive 100 mcg intrathecal morphine in addition to 15 mg of 0.5% hyperbaric bupivacaine during spinal anesthesia.
Experimental: TFP Block Group
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.
Patients will receive an ultrasound-guided unilateral transversalis fascia plane block on the surgical side using 30 mL of 0.25% bupivacaine before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after surgery
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.
0-24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2026

Primary Completion (Estimated)

October 23, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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