Postoperative PainTEP-APNCT07787871
Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair
A study testing Acupressure in people with Postoperative Pain and Inguinal Hernia, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, sham-controlled clinical trial aims to evaluate the effect of acupressure on postoperative pain following laparoscopic totally extraperitoneal (TEP) inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia
- What is being tested?
- Acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2026to 31 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Diagnosis of a unilateral primary inguinal hernia
- Scheduled to undergo elective laparoscopic total extraperitoneal (TEP) inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I to III without an anticipated need for postoperative intensive care
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Bilateral inguinal hernia
- Recurrent inguinal hernia
- Strangulated inguinal hernia
- History of open lower abdominal surgery
- Skin infection, wound, or surgical scar at any of the acupressure application sites
- ASA physical status III with an anticipated need for postoperative intensive care
Show all 10Show fewer
- ASA physical status IV
- Participation in another clinical study within the previous 4 weeks
- Receipt of acupressure or a similar complementary treatment within the previous 4 weeks
- Refusal or inability to provide written informed consent
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
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752
About this study
Official title: The Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair: A Prospective Three-Arm Randomized Sham-Controlled Clinical Trial
This randomized, sham-controlled clinical trial aims to evaluate the effect of acupressure on postoperative pain following laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
A total of 90 participants will be randomly assigned to one of three groups: standard postoperative care alone (control group), true acupressure plus standard care, or sham acupressure plus standard care. Acupressure will be applied at postoperative hours 1, 4, and 8 using the bilateral P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao) acupoints. The sham group will receive pressure at non-acupuncture points.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include analgesic consumption, postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.
Read the detailed description
Postoperative pain after laparoscopic totally extraperitoneal (TEP) inguinal hernia repair remains an important clinical problem despite advances in minimally invasive surgery. Acupressure is a non-invasive complementary therapy that may reduce postoperative pain and improve recovery.
This prospective, randomized, sham-controlled, three-arm clinical trial will enroll 90 adult patients undergoing elective laparoscopic TEP inguinal hernia repair.
Participants will be randomly allocated in a 1:1:1 ratio into:
- Control group: Standard postoperative care only.
- Acupressure group: Standard postoperative care plus bilateral acupressure applied at P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao).
- Sham acupressure group: Standard postoperative care plus pressure applied to non-acupuncture points.
Each intervention will be administered at postoperative hours 1, 4, and 8. Pressure will be applied manually for approximately 3 minutes at each point bilaterally by trained personnel.
Pain intensity will be evaluated using the Visual Analog Scale (VAS) at predetermined postoperative time points. Secondary outcomes include total analgesic consumption, incidence of postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.
The study is designed to determine whether true acupressure provides additional benefit beyond standard care and whether its effects differ from sham acupressure, thereby distinguishing specific therapeutic effects from placebo responses.
- Conditions
- Postoperative Pain, Inguinal Hernia
- Being tested
- Acupressure, Sham Acupressure
- Keywords
- Acupressure, Sham Acupressure, TEP, Laparoscopic Totally Extraperitoneal Hernia Repair, Inguinal Hernia, Postoperative Pain, Randomized Controlled Trial, Visual Analog Scale, Complementary Medicine
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureProcedure or surgery
Bilateral acupressure is applied at P6, LI4, ST36, and SP6 for 3 minutes per point at postoperative 1, 4, and 8 hours.
Sham AcupressureProcedure or surgery
Manual pressure is applied to non-acupuncture points using the same duration and schedule as the active acupressure intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive standard postoperative care without acupressure. |
| Acupressure | Experimental | Participants receive standard postoperative care plus true acupressure at bilateral P6, LI4, ST36, and SP6 points for 3 minutes per point at postoperative 1, 4, and 8 hours. Receives: Procedure: Acupressure |
| Sham Acupressure | Sham comparator | Participants receive standard postoperative care plus sham acupressure at non-acupoint locations with the same duration and schedule as the acupressure group. Receives: Procedure: Sham Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by Visual Analog Scale
Postoperative pain intensity will be assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be recorded at postoperative hours 2, 4, 6, 12, and 24 and compared among the study groups.
Measured: At postoperative hours 2, 4, 6, 12, and 24
Secondary outcomes (4)
Rescue Analgesic Requirement
The requirement for rescue analgesic medication and the number of analgesic administrations will be recorded from the patient medication chart and compared among the study groups.
Measured: During the first 24 postoperative hours
Incidence of Postoperative Nausea and Vomiting
The presence of postoperative nausea and the number of vomiting episodes will be recorded and compared among the study groups.
Measured: During the first 24 postoperative hours
Early Postoperative Complications
The occurrence and type of early postoperative complications will be recorded and compared among the study groups.
Measured: During the first 24 postoperative hours
Rescue Antiemetic Requirement
The requirement for rescue antiemetic medication and the number of antiemetic administrations will be recorded from the patient medication chart and compared among the study groups.
Measured: During the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start20 Jun 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 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.
- More trials run by Medipol UniversityThe 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
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: control, acupressure, or sham acupressure.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Fatih Sultan Mehmet Training and Research Hospital
- Responsible party
- Principal investigator, ahmet said yaz, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787871
- Sponsor's protocol ID
- MEDIPOL-GETAT-2026-001
- Acronym
- TEP-AP
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available due to participant confidentiality and institutional data protection requirements. Aggregate study results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair: A Prospective Three-Arm Randomized Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07787871
- Acronym / sponsor ID
- TEP-AP / MEDIPOL-GETAT-2026-001
- Conditions
- Postoperative Pain, Inguinal Hernia
- Keywords
- Acupressure, Sham Acupressure, TEP, Laparoscopic Totally Extraperitoneal Hernia Repair, Inguinal Hernia, Postoperative Pain, Randomized Controlled Trial, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Fatih Sultan Mehmet Training and Research Hospital
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Aug 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.
This randomized, sham-controlled clinical trial aims to evaluate the effect of acupressure on postoperative pain following laparoscopic totally extraperitoneal (TEP) inguinal hernia repair.
A total of 90 participants will be randomly assigned to one of three groups: standard postoperative care alone (control group), true acupressure plus standard care, or sham acupressure plus standard care. Acupressure will be applied at postoperative hours 1, 4, and 8 using the bilateral P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao) acupoints. The sham group will receive pressure at non-acupuncture points.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include analgesic consumption, postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.
Detailed description
Postoperative pain after laparoscopic totally extraperitoneal (TEP) inguinal hernia repair remains an important clinical problem despite advances in minimally invasive surgery. Acupressure is a non-invasive complementary therapy that may reduce postoperative pain and improve recovery.
This prospective, randomized, sham-controlled, three-arm clinical trial will enroll 90 adult patients undergoing elective laparoscopic TEP inguinal hernia repair.
Participants will be randomly allocated in a 1:1:1 ratio into:
- Control group: Standard postoperative care only.
- Acupressure group: Standard postoperative care plus bilateral acupressure applied at P6 (Neiguan), LI4 (Hegu), ST36 (Zusanli), and SP6 (Sanyinjiao).
- Sham acupressure group: Standard postoperative care plus pressure applied to non-acupuncture points.
Each intervention will be administered at postoperative hours 1, 4, and 8. Pressure will be applied manually for approximately 3 minutes at each point bilaterally by trained personnel.
Pain intensity will be evaluated using the Visual Analog Scale (VAS) at predetermined postoperative time points. Secondary outcomes include total analgesic consumption, incidence of postoperative nausea and vomiting, time to mobilization, patient satisfaction, and postoperative complications.
The study is designed to determine whether true acupressure provides additional benefit beyond standard care and whether its effects differ from sham acupressure, thereby distinguishing specific therapeutic effects from placebo responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: control, acupressure, or sham acupressure.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive standard postoperative care without acupressure. |
| Acupressure | Experimental | Procedure: AcupressureParticipants receive standard postoperative care plus true acupressure at bilateral P6, LI4, ST36, and SP6 points for 3 minutes per point at postoperative 1, 4, and 8 hours. |
| Sham Acupressure | Sham comparator | Procedure: Sham AcupressureParticipants receive standard postoperative care plus sham acupressure at non-acupoint locations with the same duration and schedule as the acupressure group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years
- Diagnosis of a unilateral primary inguinal hernia
- Scheduled to undergo elective laparoscopic total extraperitoneal (TEP) inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I to III without an anticipated need for postoperative intensive care
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (10 listed)
- Bilateral inguinal hernia
- Recurrent inguinal hernia
- Strangulated inguinal hernia
- History of open lower abdominal surgery
- Skin infection, wound, or surgical scar at any of the acupressure application sites
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 |
|---|---|---|
| AcupressureBilateral acupressure is applied at P6, LI4, ST36, and SP6 for 3 minutes per point at postoperative 1, 4, and 8 hours. | Procedure or surgery | Acupressure |
| Sham AcupressureManual pressure is applied to non-acupuncture points using the same duration and schedule as the active acupressure intervention. | Procedure or surgery | Sham Acupressure |
Primary outcome
Postoperative Pain Intensity Assessed by Visual Analog Scale
Time frame: At postoperative hours 2, 4, 6, 12, and 24
Postoperative pain intensity will be assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be recorded at postoperative hours 2, 4, 6, 12, and 24 and compared among the study groups.
4 secondary outcomes
Rescue Analgesic Requirement
Time frame: During the first 24 postoperative hours
Incidence of Postoperative Nausea and Vomiting
Time frame: During the first 24 postoperative hours
Early Postoperative Complications
Time frame: During the first 24 postoperative hours
Rescue Antiemetic Requirement
Time frame: During the first 24 postoperative hours
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 26 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available due to participant confidentiality and institutional data protection requirements. Aggregate study results will be reported in scientific publications.
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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 Acupressure in people with Postoperative Pain and Inguinal Hernia, run by Medipol 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 5 inclusion and 10 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 26 Aug 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. 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 AHMET S YAZ, MD (+902165783000, ahmet.yaz@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Assessed by Visual Analog Scale (time frame: At postoperative hours 2, 4, 6, 12, and 24). 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 26 Aug 2026.