Effectiveness of Fentanyl-Added TAP Block in Laparoscopic Cholecystectomy
ConditionPostoperative Pain, Acute
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUludag University
About this trial
The aim of this study is to evaluate the effectiveness of adding fentanyl to the TAP block in laparoscopic cholecystectomy cases. It is hypothesized that the addition of fentanyl to the TAP block will enhance the quality of postoperative analgesia and prolong the duration of blockade compared to the TAP block performed with bupivacaine alone. The study aims to determine the most effective approach by comparing these two treatment methods with a control group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged 18 to 70 years
American Society of Anesthesiologists (ASA) classification I-II-III according to the American Society of Anesthesiologists
Patients who provide written informed consent
Patients scheduled for elective laparoscopic cholecystectomy
Disqualifiers
Pregnancy or suspected pregnancy
BMI > 35
Known allergy to local anesthetics or opioids
Suspected coagulopathy or infection at the injection site
Trial design
Design model
Parallel
Treatments tested in this trial
TAP block with bupivacaine only
Procedure/SurgeryPatients undergoing laparoscopic cholecystectomy will receive TAP block with bupivacaine only after induction and before the surgical procedure begins.
TAP block with bupivacaine and fentanyl
Procedure/SurgeryPatients undergoing laparoscopic cholecystectomy will receive a TAP block with bupivacaine and fentanyl after induction and before the surgical procedure begins
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Group 1Active comparator 1 intervention
Group B: Group 2Active comparator 1 intervention
Group C: Group 3No intervention 0 interventions
Trial outcomes
Primary outcomes
1
The Visual Analog Scale
The Visual Analog Scale (VAS) is a simple and widely used tool to assess the intensity of pain or symptoms. It helps convert patients' subjective experiences (such as pain, discomfort, or fatigue) into a numerical value. This scale is particularly useful in evaluating postoperative pain and chronic pain conditions. How Does VAS Work? The VAS typically consists of a 10 cm horizontal or vertical line. One end of the line is labeled "No Pain", and the other end is labeled "Worst Pain Possible". The patient is asked to mark a point on the line that best represents their pain intensity. The marked point is measured with a ruler to obtain a score between 0 and 10. VAS Scoring: VAS Score Pain Level 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe and unbearable pain Areas of Use: Postoperative pain assessment Chronic pain management Conditions like migraine, arthritis, or cancer pain Evaluating physical and emotional symptoms (e.g., anxiety or depression)
Time frame
1 daySecondary outcomes
1
Rescue Analgesic Requirement
It will be applied to patients with a VAS score above 5.
Time frame
1 day2
The 5-point Likert scale
Patient satisfaction will be assessed using a 5-point Likert scale.The 5-point Likert scale is a widely used rating scale to measure attitudes, opinions, and perceptions in surveys and questionnaires. In clinical studies, it is often used to assess patient satisfaction, allowing patients to rate their experiences on a scale from strongly dissatisfied to strongly satisfied. Structure of the 5-Point Likert Scale: Score Response 1. Strongly Dissatisfied 2. Dissatisfied 3. Neutral 4. Satisfied 5. Strongly Satisfied
Time frame
1 dayLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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