Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair
TEP-AP
The Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair: A Prospective Three-Arm Randomized Sham-Controlled Clinical Trial
1 other identifier
interventional
90
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jun 2026
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2026
CompletedFirst Submitted
Initial submission to the registry
August 23, 2026
CompletedFirst Posted
Study publicly available on registry
August 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
August 26, 2026
August 1, 2026
4 months
August 23, 2026
August 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At postoperative hours 2, 4, 6, 12, and 24
Secondary Outcomes (4)
Rescue Analgesic Requirement
During the first 24 postoperative hours
Incidence of Postoperative Nausea and Vomiting
During the first 24 postoperative hours
Early Postoperative Complications
During the first 24 postoperative hours
Rescue Antiemetic Requirement
During the first 24 postoperative hours
Study Arms (3)
Control
NO INTERVENTIONParticipants receive standard postoperative care without acupressure.
Acupressure
EXPERIMENTALParticipants 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 COMPARATORParticipants receive standard postoperative care plus sham acupressure at non-acupoint locations with the same duration and schedule as the acupressure group.
Interventions
Bilateral acupressure is applied at P6, LI4, ST36, and SP6 for 3 minutes per point at postoperative 1, 4, and 8 hours.
Manual pressure is applied to non-acupuncture points using the same duration and schedule as the active acupressure intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessors will be blinded to treatment allocation. The practitioner delivering the intervention cannot be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 23, 2026
First Posted
August 26, 2026
Study Start
June 20, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
August 26, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.