Effectiveness of Fentanyl-Added TAP Block in Laparoscopic Cholecystectomy

NCT06778668 | Not Yet Recruiting

• 1 other identifier: UU-AN-MC-01
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain, Acute

Outcome Measures

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)

  1 day

Secondary Outcomes (2)

• Rescue Analgesic Requirement

  1 day

• The 5-point Likert scale

  1 day

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Group 1, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device routinely used in our clinic. The procedure will be performed in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region (an anatomical area following the lower border of the ribs). A 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of 0.25% bupivacaine solution will be administered, with a maximum dose of 2 mg/kg.

Procedure: TAP block with bupivacaine only

Group 2

ACTIVE COMPARATOR

In Group 2, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region, and a 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of block solution containing 0.25% bupivacaine and 50 mcg fentanyl will be administered.

Procedure: TAP block with bupivacaine and fentanyl

Group 3

NO INTERVENTION

Patients in Group 3 will serve as the control group, and no block will be applied.

Interventions

TAP block with bupivacaine only PROCEDURE

Patients undergoing laparoscopic cholecystectomy will receive TAP block with bupivacaine only after induction and before the surgical procedure begins.

Group 1

TAP block with bupivacaine and fentanyl PROCEDURE

Patients undergoing laparoscopic cholecystectomy will receive a TAP block with bupivacaine and fentanyl after induction and before the surgical procedure begins

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or suspected pregnancy
• BMI \> 35
• Known allergy to local anesthetics or opioids
• Suspected coagulopathy or infection at the injection site
• Severe neurological, psychiatric, cardiovascular, liver, or renal failure
• Patients converted to open surgery intraoperatively

Sponsors & Collaborators

• Uludag University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is a double-blind randomized trial. Both the researchers assessing postoperative pain and the participants will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: Patients will be randomized into three groups: Group 1: TAP block with bupivacaine only, Group 2: TAP block with bupivacaine and fentanyl, Group 3: Control group (no TAP block).

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: February 10, 2025
• Primary Completion: February 9, 2026
• Study Completion: February 10, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01