Authors
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Sanliurfa Education and Research Hospital -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Laparoscopic cholecystectomy (LC) is associated with less postoperative pain comparedwith open cholecystectomy; however, postoperative pain of varying severity may stilloccur due to pneumoperitoneum, surgical manipulation, and patient‐related factors.Multimodal analgesia strategies including systemic non‐opioid analgesics, opioids, localanesthetic infiltration, and interfascial plane blocks are widely recommended forpostoperative pain management after LC. Inadequate pain control may prolong hospitalstay, increase morbidity, and elevate healthcare costs.Ultrasound‐guided transversus abdominis plane (TAP) block has become an importantcomponent of perioperative analgesia in abdominal surgery by reducing opioid consumptionand improving recovery quality. Current PROSPECT recommendations support the use of TAPblock as an effective regional analgesia technique following laparoscopiccholecystectomy.Beyond pharmacological and regional analgesic techniques, patient‐related psychosocialfactors may significantly influence perioperative outcomes. Physician trust has beenshown to affect treatment adherence, perceived quality of care, pain perception, andfunctional recovery. Similarly, preoperative anxiety may influence postoperative painintensity and patient satisfaction. The Trust in Physician Scale and the AmsterdamPreoperative Anxiety and Information Scale (APAIS) are validated instruments commonlyused to assess physician trust and preoperative anxiety, respectively.Video‐based preoperative education has emerged as a standardized and visually supportededucational tool that may reduce anxiety, improve patient satisfaction, optimize patientexpectations, and strengthen physician‐patient relationships. Digital multimediaplatforms are increasingly utilized in medical education, including procedural educationfor regional anesthesia techniques. However, there is limited evidence evaluating theimpact of video‐based education on patient‐centered outcomes in the context of regionalanesthesia.The primary objective of this study is to determine whether video‐based preoperativeeducation regarding TAP block improves physician trust compared with standard verbalinformation alone in patients undergoing laparoscopic cholecystectomy. Secondaryobjectives are to evaluate the effects of video‐based education on postoperative painscores, opioid consumption, rescue analgesic requirement, postoperative nausea andvomiting (PONV), and preoperative anxiety levels.This study is designed as a prospective, randomized, single‐center, single‐blindcontrolled trial. A total of 62 patients aged 18‐65 years with American Society ofAnesthesiologists (ASA) physical status I‐II scheduled for elective laparoscopiccholecystectomy will be enrolled. Exclusion criteria include psychiatric disease,anticoagulant use or coagulopathy, allergy to local anesthetics, infection at the blocksite, thoracic deformity, and inability to comprehend pain or anxiety assessment scales.Participants will be randomized into two groups using a sealed‐envelope method:Control group: standard verbal preoperative information about TAP block Video group:standard verbal information plus a standardized educational video demonstratingultrasound anatomy and probe positioning for TAP block without showing invasiveprocedural stepsApproximately one hour before surgery, preoperative anxiety will be evaluated using theAPAIS questionnaire. All patients will undergo standardized general anesthesia andreceive multimodal analgesia including dexketoprofen and tramadol before the end ofsurgery. Ultrasound‐guided bilateral TAP block will be performed in all patients.Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) at 0,4, 12, and 24 hours postoperatively. Rescue analgesic requirements and total opioidconsumption converted to intravenous morphine equivalents will be recorded. Physiciantrust will be assessed at postoperative 24 hours using the Trust in Physician Scale andwill serve as the primary endpoint. Secondary endpoints include postoperative NRS painscores, opioid consumption, preoperative anxiety scores, rescue analgesic requirement,and incidence of postoperative nausea and vomiting.Sample size calculation will be performed using G*Power software based on pilot data, and31 patients will be included in each group considering possible dropouts. Statisticalanalyses will be conducted using SPSS software. Normality of data distribution will beassessed with the Shapiro‐Wilk test. Appropriate parametric or non‐parametric statisticaltests will be used accordingly, and a p‐value <0.05 will be considered statisticallysignificant.
Epistemonikos ID: 1ef8f3929364b8f67de3813cac170ecafff6e76c
First added on: Aug 17, 2026