Effect of Acupressure on Postoperative Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedipol University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Acupressure
Procedure/SurgeryBilateral acupressure is applied at P6, LI4, ST36, and SP6 for 3 minutes per point at postoperative 1, 4, and 8 hours.
Sham Acupressure
Procedure/SurgeryManual pressure is applied to non-acupuncture points using the same duration and schedule as the active acupressure intervention.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: AcupressureExperimental treatment 1 intervention
Group C: Sham AcupressureSham comparator 1 intervention
Trial outcomes
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.
Time frame
At postoperative hours 2, 4, 6, 12, and 24Secondary outcomes
1
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.
Time frame
During the first 24 postoperative hours2
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.
Time frame
During the first 24 postoperative hours3
Early Postoperative Complications
The occurrence and type of early postoperative complications will be recorded and compared among the study groups.
Time frame
During the first 24 postoperative hours4
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.
Time frame
During the first 24 postoperative hoursSponsors and contacts
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Medipol University
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Collaborator
Source ClinicalTrials.gov