Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07787871
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Istanbul, 34752, Turkey (Türkiye)
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral inguinal hernia
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: During the first 24 postoperative hours
The occurrence and type of early postoperative complications will be recorded and compared among the study groups.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Medipol University
Other
The Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair: A Prospective Three-Arm Randomized Sham-Controlled Clinical Trial
Acronym: TEP-AP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05929937
Hernia, Hernia, Abdominal
Fountain Valley, California, United States
View Trial DetailsNCT05847842
Hernia, Hernia, Abdominal
Eskişehir, Turkey (Türkiye)
View Trial DetailsNCT07319754
Hernia, Hernia, Abdominal
Adana, Turkey (Türkiye)
View Trial DetailsNCT05522608
Hernia, Hernia, Abdominal
Izmir, Turkey (Türkiye)
View Trial Details