Pain, PostoperativeNCT07826741
Intrathecal Morphine and Transversalis Fascia Plane Block for Analgesia After Open Inguinal Hernia Repair
A study testing Intrathecal Morphine Group and Transversalis Fascia Plane Block Group in people with Pain, Postoperative and Inguinal Hernia Unilateral, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Inguinal Hernia Unilateral, Intrathecal Morphine
- What is being tested?
- Intrathecal Morphine Group and Transversalis Fascia Plane Block Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2026to 25 Apr 2027
- 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
- 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
Who cannot join
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic and morphine allergy
- Infection in the intervention area
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
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
Musa Zengin, Associate Professor, 00905307716235, musazengin@gmail.com
Şule Küreşci Karagöz, Medical Doctor, 00905526825835, suleekuresci@gmail.com
About this study
Official title: Comparison of Intrathecal Morphine, Transversalis Fascia Plane Block, and Spinal Anesthesia Alone for Postoperative Analgesia in Open Inguinal Hernia Repair: A Prospective, Randomized, Assessor-Blinded, Controlled Trial
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
- Pain, Postoperative, Inguinal Hernia Unilateral, Intrathecal Morphine, Transversalis Fascia Plane Block, Multimodal Analgesia
- Being tested
- Intrathecal Morphine Group, Transversalis Fascia Plane Block Group, Control Group
- 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 Morphine GroupProcedure or surgery
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.
Transversalis Fascia Plane Block GroupProcedure or surgery
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.
Control GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours after surgery
Secondary outcomes (4)
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.
Measured: Up to 24 hours after surgery
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.
Measured: Up to 24 hours after surgery
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.
Measured: Up to 24 hours after surgery
Side effects
Side effects, such as allergy , hypotension, nausea/vomiting, and itching, will be recorded.
Measured: Up to 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 posted17 Sep 2026
- Study start18 Sep 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826741
- Sponsor's protocol ID
- AEŞH-EK-2026-202
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Morphine, Transversalis Fascia Plane Block, and Spinal Anesthesia Alone for Postoperative Analgesia in Open Inguinal Hernia Repair: A Prospective, Randomized, Assessor-Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT07826741
- Acronym / sponsor ID
- AEŞH-EK-2026-202
- Conditions
- Pain, Postoperative, Inguinal Hernia Unilateral, Intrathecal Morphine, Transversalis Fascia Plane Block, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 17 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Active comparator | Procedure: Intrathecal Morphine GroupParticipants 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. |
| Transversalis Fascia Plane Block | Active comparator | Procedure: Transversalis Fascia Plane Block GroupParticipants 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. |
| Spinal Anesthesia Alone | Active comparator | Procedure: Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic and morphine allergy
- Infection in the intervention area
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 Morphine GroupSpinal 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. | Procedure or surgery | Intrathecal Morphine |
| Transversalis Fascia Plane Block GroupSpinal 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. | Procedure or surgery | Transversalis Fascia Plane Block |
| Control GroupSpinal 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. | Procedure or surgery | Spinal Anesthesia Alone |
Primary outcome
Morphine Consumption via Patient-Controlled Analgesia
Time frame: Up to 24 hours after surgery
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.
4 secondary outcomes
Pain scores
Time frame: Up to 24 hours after surgery
Pain scores
Time frame: Up to 24 hours after surgery
Total Rescue Tramadol Consumption
Time frame: Up to 24 hours after surgery
Side effects
Time frame: Up to 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 21 Sep 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 Group and Transversalis Fascia Plane Block Group in people with Pain, Postoperative and Inguinal Hernia Unilateral, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 4 inclusion and 4 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 21 Sep 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 Musa Zengin, Associate Professor (00905307716235, musazengin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption via Patient-Controlled Analgesia (time frame: Up to 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 21 Sep 2026.