Postoperative PainNCT07695935
Transversalis Fascia Plane Block Versus Low-Dose Intrathecal Morphine for Open Inguinal Hernia Repair
A study testing Intrathecal morphine and Ultrasound-guided transversalis fascia plane block in people with Postoperative Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intrathecal morphine and Ultrasound-guided transversalis fascia plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Refusal to participate
- Bilateral inguinal hernia repair
- Recurrent inguinal hernia repair
- Emergency, incarcerated, or strangulated hernia
- Need for general anesthesia
- Contraindication to spinal anesthesia
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit university
Çorum
Ozgur Yagan, Professor
About this study
Official 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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Intrathecal morphine, Ultrasound-guided transversalis fascia plane block
- Keywords
- Postoperative analgesia, Transversalis fascia plane block, Opioid consumption, Regional anesthesia, Intrathecal morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
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 blockProcedure or surgery
Patients will receive an ultrasound-guided unilateral transversalis fascia plane block on the surgical side using 30 mL of 0.25% bupivacaine before surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Ultrasound-guided transversalis fascia plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-24 hours after surgery
Secondary outcomes (2)
Quality of Recovery Score
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.
Measured: 24 hours after surgery
Opioid-Related Adverse Effects
Nausea, vomiting, pruritus, urinary retention, sedation, respiratory depression, and oxygen desaturation will be recorded.
Measured: 0-24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start23 Jun 2026
- Primary completion23 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Onen Ozdemir, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695935
- Sponsor's protocol ID
- 2026-32
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07695935
- Acronym / sponsor ID
- 2026-32
- Conditions
- Postoperative Pain
- Keywords
- Postoperative analgesia, Transversalis fascia plane block, Opioid consumption, Regional anesthesia, Intrathecal morphine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine Group | Active comparator | Drug: Intrathecal morphinePatients will receive spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine plus 100 mcg intrathecal morphine. No TFP block will be performed. |
| TFP Block Group | Experimental | Procedure: Ultrasound-guided transversalis fascia plane blockAn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Refusal to participate
- Bilateral inguinal hernia repair
- Recurrent inguinal hernia repair
- Emergency, incarcerated, or strangulated hernia
- Need for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphinePatients will receive 100 mcg intrathecal morphine in addition to 15 mg of 0.5% hyperbaric bupivacaine during spinal anesthesia. | Drug | Intrathecal Morphine Group |
| Ultrasound-guided transversalis fascia plane blockPatients will receive an ultrasound-guided unilateral transversalis fascia plane block on the surgical side using 30 mL of 0.25% bupivacaine before surgery. | Procedure or surgery | TFP Block Group |
Primary outcome
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.
2 secondary outcomes
Quality of Recovery Score
Time frame: 24 hours after surgery
Opioid-Related Adverse Effects
Time frame: 0-24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine and Ultrasound-guided transversalis fascia plane block in people with Postoperative Pain, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibel Onen Ozdemir, MD (+905442892194, sibelonen89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Rescue Opioid Consumption During the First 24 Postoperative Hours (time frame: 0-24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.