Inguinal HerniaPRO-RSTAPNCT07423910
PRO-RSTAP: Effect of TAP and RS Blocks on Recovery After Inguinal Hernia Surgery (PRO-RSTAP)
A study testing Transversus abdominis plane block (TAP block), Rectus sheath block (active) and Ropivacaine in people with Inguinal Hernia, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Inguinal hernia repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Transversus abdominis plane block (TAP block), Rectus sheath block (active) and Ropivacaine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jul 2025to Jan 2038
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Elective unilateral open inguinal hernia repair
- Ability to provide written informed consent
Who cannot join
- Emergency surgery
- Bilateral or recurrent inguinal hernia
- Contraindication to regional anesthesia or study interventions
- Known allergy to local anesthetics
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Medial Transversus Abdominis Plane (TAP) Block and Rectus Sheath (RS) Block on Inguinal Hernia Surgery Recovery, a Prospective Randomized Double-blind Study (PRO-RSTAP)
Inguinal hernia repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission.
The PRO-RSTAP study is a prospective, randomized, double-blind clinical trial evaluating whether ultrasound-guided transversus abdominis plane (TAP) block, rectus sheath (RS) block, or their combination improves postoperative recovery after open inguinal hernia surgery. Adult patients undergoing unilateral open inguinal hernia repair are randomized into four groups receiving either combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks , in addition to standard perioperative care.
Read more
The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalents. Secondary outcomes include postoperative pain scores, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, unplanned hospital admission, and chronic postoperative pain during long-term follow-up.
The aim of this study is to determine the individual and combined effects of TAP and RS blocks on postoperative analgesia and recovery in patients undergoing open inguinal hernia repair.
Read the detailed description
This study is a prospective, randomized, double-blind clinical trial evaluating the effects of ultrasound-guided transversus abdominis plane (TAP) block and rectus sheath (RS) block on postoperative recovery after open inguinal hernia surgery. The study uses a 2 × 2 factorial design, with participants randomized into four groups receiving combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks, in addition to standard perioperative care.
The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalent dose. Secondary outcomes include postoperative pain intensity, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, and unplanned hospital admission.
- Conditions
- Inguinal Hernia
- Being tested
- Transversus abdominis plane block (TAP block), Rectus sheath block (active), Placebo nerve block, Ropivacaine, Sodium chloride
- Keywords
- Open inguinal hernia repair, Regional anesthesia, Transversus abdominis plane block, Rectus sheath block, Postoperative analgesia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane block (TAP block)Procedure or surgery
Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia.
Rectus sheath block (active)Procedure or surgery
Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia.
Placebo nerve blockProcedure or surgery
Ultrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic.
RopivacaineDrug
Ropivacaine 7.5 mg/ml diluted 1:1 with saline, used for active transversus abdominis plane (TAP) and/or rectus sheath (RS) blocks administered preoperatively for postoperative analgesia.
Sodium chlorideDrug
0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding.
Ultrasound deviceDevice
Ultrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks.
MorphineDrug
Standard perioperative opioid analgesics administered intraoperatively and postoperatively according to institutional protocol. Opioid doses are recorded and converted to intravenous morphine equivalent dose for outcome assessment.
| Study group | Role | What they receive |
|---|---|---|
| Combined TAP + RS block | Experimental | Participants receive active TAP block and active RS block in addition to standard perioperative care. Receives: Procedure: Transversus abdominis plane block (TAP block); Procedure: Rectus sheath block (active); Drug: Ropivacaine; Device: Ultrasound device; Drug: Morphine |
| TAP block only | Experimental | Participants receive active TAP block and placebo RS block in addition to standard perioperative care. Receives: Procedure: Transversus abdominis plane block (TAP block); Procedure: Placebo nerve block; Drug: Ropivacaine; Drug: Sodium chloride; Device: Ultrasound device; Drug: Morphine |
| RS block only | Experimental | Participants receive active RS block and placebo TAP block in addition to standard perioperative care. Receives: Procedure: Rectus sheath block (active); Procedure: Placebo nerve block; Drug: Ropivacaine; Drug: Sodium chloride; Device: Ultrasound device; Drug: Morphine |
| Placebo TAP + Placebo RS | Placebo comparator | Participants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care. Receives: Procedure: Placebo nerve block; Drug: Sodium chloride; Device: Ultrasound device; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative opioid consumption (intravenous morphine equivalent dose, mg)
Total cumulative opioid dose administered intraoperatively and postoperatively, converted to intravenous morphine equivalent dose (mg) using standardized equianalgesic conversion factors.
Measured: Perioperative/Periprocedural
Secondary outcomes (6)
Postoperative pain intensity (Numeric Rating Scale, NRS 0-10)
Postoperative pain intensity assessed using a Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 1 hour and 24 hours after surgery
Number of participants requiring rescue analgesia within 24 hours
Number of participants requiring additional rescue analgesic medication due to inadequate pain control.
Measured: Up to 24 hours
Number of participants with postoperative nausea and/or vomiting
Occurrence of postoperative nausea and/or vomiting and need for antiemetic medication.
Measured: Up to 24 hours
Time to fulfillment of discharge criteria
Time from completion of surgery to fulfillment of predefined discharge criteria according to institutional day-surgery protocol
Measured: Up to 24 hours
Number of participants with unplanned hospital admission within 24 hours
Number of participants requiring unplanned hospital admission or prolonged hospital stay following planned day-case surgery.
Measured: Up to 24 hours
Presence of chronic postoperative pain
Presence of persistent postoperative pain assessed during follow-up using patient self-report.
Measured: 1 week and 1, 3, 5, and 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jul 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- This is a 2 × 2 factorial randomized study evaluating the individual and combined effects of rectus sheath (RS) block and transversus abdominis plane (TAP) block. Participants are randomized into four groups receiving combined RS and TAP blocks, TAP block only, RS block only, or placebo blocks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aki Lumme, Principal investigator, Tampere University Hospital, Pirkanmaa Wellbeing Services County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423910
- Sponsor's protocol ID
- R24107M
- Other IDs
- 2024-513406-59-00
- Acronym
- PRO-RSTAP
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nordstrom P, Lumme A, Virman J, Kalliomaki ML. Combined Transversus Abdominis Plane and Rectus Sheath Blocks in Open Inguinal Hernia Repair: Protocol for a Double-Blind Randomized Controlled Trial (PRO-RSTAP). Acta Anaesthesiol Scand. 2026 Jul;70(6):e70238. doi: 10.1111/aas.70238.
PubMed 42089120
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medial Transversus Abdominis Plane (TAP) Block and Rectus Sheath (RS) Block on Inguinal Hernia Surgery Recovery, a Prospective Randomized Double-blind Study (PRO-RSTAP)
- ClinicalTrials.gov ID
- NCT07423910
- Acronym / sponsor ID
- PRO-RSTAP / R24107M
- Conditions
- Inguinal Hernia
- Keywords
- Open inguinal hernia repair, Regional anesthesia, Transversus abdominis plane block, Rectus sheath block, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2038 (estimated)
- First posted
- 20 Feb 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 repair is a common surgical procedure, often performed as day-case surgery. Despite standardized surgical techniques, postoperative pain may delay recovery and occasionally lead to unplanned hospital admission.
The PRO-RSTAP study is a prospective, randomized, double-blind clinical trial evaluating whether ultrasound-guided transversus abdominis plane (TAP) block, rectus sheath (RS) block, or their combination improves postoperative recovery after open inguinal hernia surgery. Adult patients undergoing unilateral open inguinal hernia repair are randomized into four groups receiving either combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks , in addition to standard perioperative care.
The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalents. Secondary outcomes include postoperative pain scores, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, unplanned hospital admission, and chronic postoperative pain during long-term follow-up.
The aim of this study is to determine the individual and combined effects of TAP and RS blocks on postoperative analgesia and recovery in patients undergoing open inguinal hernia repair.
Detailed description
This study is a prospective, randomized, double-blind clinical trial evaluating the effects of ultrasound-guided transversus abdominis plane (TAP) block and rectus sheath (RS) block on postoperative recovery after open inguinal hernia surgery. The study uses a 2 × 2 factorial design, with participants randomized into four groups receiving combined TAP and RS blocks, TAP block only, RS block only, or placebo blocks, in addition to standard perioperative care.
The primary outcome is total perioperative opioid consumption measured as intravenous morphine equivalent dose. Secondary outcomes include postoperative pain intensity, need for rescue analgesia, postoperative nausea and vomiting, time to discharge, and unplanned hospital admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 2 × 2 factorial randomized study evaluating the individual and combined effects of rectus sheath (RS) block and transversus abdominis plane (TAP) block. Participants are randomized into four groups receiving combined RS and TAP blocks, TAP block only, RS block only, or placebo blocks.
| Arm | Type | Receives |
|---|---|---|
| Combined TAP + RS block | Experimental | Procedure: Transversus abdominis plane block (TAP block), Procedure: Rectus sheath block (active), Drug: Ropivacaine, Device: Ultrasound device, Drug: MorphineParticipants receive active TAP block and active RS block in addition to standard perioperative care. |
| TAP block only | Experimental | Procedure: Transversus abdominis plane block (TAP block), Procedure: Placebo nerve block, Drug: Ropivacaine, Drug: Sodium chloride, Device: Ultrasound device, Drug: MorphineParticipants receive active TAP block and placebo RS block in addition to standard perioperative care. |
| RS block only | Experimental | Procedure: Rectus sheath block (active), Procedure: Placebo nerve block, Drug: Ropivacaine, Drug: Sodium chloride, Device: Ultrasound device, Drug: MorphineParticipants receive active RS block and placebo TAP block in addition to standard perioperative care. |
| Placebo TAP + Placebo RS | Placebo comparator | Procedure: Placebo nerve block, Drug: Sodium chloride, Device: Ultrasound device, Drug: MorphineParticipants receive placebo transversus abdominis plane (TAP) block and placebo rectus sheath (RS) block in addition to standard perioperative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Elective unilateral open inguinal hernia repair
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Emergency surgery
- Bilateral or recurrent inguinal hernia
- Contraindication to regional anesthesia or study interventions
- Known allergy to local anesthetics
- Inability to comply with study procedures
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 |
|---|---|---|
| Transversus abdominis plane block (TAP block)Ultrasound-guided transversus abdominis plane (TAP) block performed preoperatively using local anesthetic for postoperative analgesia. | Procedure or surgery | Combined TAP + RS block, TAP block only |
| Rectus sheath block (active)Ultrasound-guided rectus sheath (RS) block performed preoperatively using local anesthetic for postoperative analgesia. | Procedure or surgery | Combined TAP + RS block, RS block only |
| Placebo nerve blockUltrasound-guided sham block performed using saline to maintain blinding, without active local anesthetic. | Procedure or surgery | Placebo TAP + Placebo RS, RS block only, TAP block only |
| RopivacaineRopivacaine 7.5 mg/ml diluted 1:1 with saline, used for active transversus abdominis plane (TAP) and/or rectus sheath (RS) blocks administered preoperatively for postoperative analgesia. | Drug | Combined TAP + RS block, RS block only, TAP block only |
| Sodium chloride0.9% sodium chloride solution used as placebo in sham transversus abdominis plane (TAP) and rectus sheath (RS) blocks to maintain blinding. | Drug | Placebo TAP + Placebo RS, RS block only, TAP block only |
| Ultrasound deviceUltrasound guidance used to perform transversus abdominis plane (TAP) and rectus sheath (RS) blocks. | Device | Combined TAP + RS block, Placebo TAP + Placebo RS, RS block only, TAP block only |
| MorphineStandard perioperative opioid analgesics administered intraoperatively and postoperatively according to institutional protocol. Opioid doses are recorded and converted to intravenous morphine equivalent dose for outcome assessment. | Drug | Combined TAP + RS block, Placebo TAP + Placebo RS, RS block only, TAP block only |
Primary outcome
Total cumulative opioid consumption (intravenous morphine equivalent dose, mg)
Time frame: Perioperative/Periprocedural
Total cumulative opioid dose administered intraoperatively and postoperatively, converted to intravenous morphine equivalent dose (mg) using standardized equianalgesic conversion factors.
6 secondary outcomes
Postoperative pain intensity (Numeric Rating Scale, NRS 0-10)
Time frame: 1 hour and 24 hours after surgery
Number of participants requiring rescue analgesia within 24 hours
Time frame: Up to 24 hours
Number of participants with postoperative nausea and/or vomiting
Time frame: Up to 24 hours
Time to fulfillment of discharge criteria
Time frame: Up to 24 hours
Number of participants with unplanned hospital admission within 24 hours
Time frame: Up to 24 hours
Presence of chronic postoperative pain
Time frame: 1 week and 1, 3, 5, and 10 years 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 20 Feb 2026.
- Derived from this study: PubMed 42089120Nordstrom P, Lumme A, Virman J, Kalliomaki ML. Combined Transversus Abdominis Plane and Rectus Sheath Blocks in Open Inguinal Hernia Repair: Protocol for a Double-Blind Randomized Controlled Trial (PRO-RSTAP). Acta Anaesthesiol Scand. 2026 Jul;70(6):e70238. doi: 10.1111/aas.70238.
- Individual participant dataSharing planned: No
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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.
Aki Lumme principal investigator
Tampere University Hospital, Pirkanmaa Wellbeing Services County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block (TAP block), Rectus sheath block (active) and Ropivacaine in people with Inguinal Hernia, run by Tampere University Hospital at 1 site in Finland.
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 3 inclusion and 5 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 20 Feb 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 Finland. 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. Some participants in this study may receive a placebo. 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 Aki Lumme, MD (+358331167232, aki.lumme@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cumulative opioid consumption (intravenous morphine equivalent dose, mg) (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07423910, which also lists 1 linked publication.
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 20 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.