Inguinal Hernia, Postoperative Pain
Conditions
Keywords
Acupressure, Sham Acupressure, TEP, Laparoscopic Totally Extraperitoneal Hernia Repair, Inguinal Hernia, Postoperative Pain, Randomized Controlled Trial, Visual Analog Scale, Complementary Medicine
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.
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.
Interventions
PROCEDUREAcupressure
Bilateral acupressure is applied at P6, LI4, ST36, and SP6 for 3 minutes per point at postoperative 1, 4, and 8 hours.
PROCEDURESham Acupressure
Manual pressure is applied to non-acupuncture points using the same duration and schedule as the active acupressure intervention.
Sponsors
Medipol University
Fatih Sultan Mehmet Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to treatment allocation. The practitioner delivering the intervention cannot be blinded.
Intervention model description
Participants will be randomly assigned to one of three parallel groups: control, acupressure, or sham acupressure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Assessed by Visual Analog Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Analgesic Requirement | During the first 24 postoperative hours | 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. |
| Incidence of Postoperative Nausea and Vomiting | During the first 24 postoperative hours | The presence of postoperative nausea and the number of vomiting episodes will be recorded and compared among the study groups. |
| Early Postoperative Complications | During the first 24 postoperative hours | The occurrence and type of early postoperative complications will be recorded and compared among the study groups. |
| Rescue Antiemetic Requirement | During the first 24 postoperative hours | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAHMET S YAZ, MD
Outcome results
None listed