ClinicalTrials.gg
RecruitingNCT07826741Updated Sep 21, 2026

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

An interventional study of Intrathecal Morphine Group and Transversalis Fascia Plane Block Group in Pain, Postoperative, Inguinal Hernia Unilateral and Intrathecal Morphine, sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Pain, Postoperative by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital — 6 open to participants now, 6 under way, none of them phase 3. Pain, Postoperative · Atatürk Chest Diseases and Chest Surgery Training and Research Hospital.

Planned enrollment
2nd of 12
90 · median 60
Started
2026
with 2 others
No phase
12 of 16
4 open now
Registered
16th of 16
by date

Among the 16 studies in Pain, Postoperative by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, this one is the 2nd largest by planned enrollment of the 12 interventional ones, is one of 3 that started in 2026, is one of 12 with no phase, and was the 16th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 4 open
Observational4 · 2 open

By the year they started

First in 2021; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 60 across the 12 interventional studies, 100 across the 4 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

03

Conditions studied

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

Browse trials for

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 80 years
  • physical status I-II-III
  • between 18 and 30 kg/m²
  • Patients undergoing elective open inguinal hernia repair

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Intrathecal Morphine

    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

  • Active comparator
    Transversalis Fascia Plane Block

    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

  • Active comparator
    Spinal Anesthesia Alone

    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

  • ProcedureIntrathecal Morphine Group

    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.

  • ProcedureTransversalis Fascia Plane Block Group

    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.

  • ProcedureControl Group

    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.

06

What researchers measure

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.

    Time frame: Up to 24 hours after surgery

Secondary outcomes

  1. Pain scores

    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.

    Time frame: Up to 24 hours after surgery

  2. Pain scores

    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.

    Time frame: Up to 24 hours after surgery

  3. Total Rescue Tramadol Consumption

    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.

    Time frame: Up to 24 hours after surgery

  4. Side effects

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

    Time frame: Up to 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Apr 2027, 6 months after the start.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 6 months is below that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2026
First posted
Sep 17, 2026
StartActual
Sep 18, 2026
Primary completionEst.
Apr 10, 2027
CompletionEst.
Apr 25, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07826741
Lead sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Responsible party
Musa Zengin (Principal Investigator, Ankara Etlik City Hospital) — Principal investigator
First posted
Sep 17, 2026
Start date
Sep 18, 2026
Primary completion
Apr 10, 2027 (estimated)
Completion
Apr 25, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Musa Zengin, Associate Professor
Contact
musazengin@gmail.com
00905307716235
Şule Küreşci Karagöz, Medical Doctor
Contact
suleekuresci@gmail.com
00905526825835

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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