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NCT Number: NCT07809009

Comparison of ANI Between Preoperative and Postoperative Ultrasound-guided TAP Block in Laparoscopic Cholecystectomy

The goal of this clinical trial is to learn if the timing of ultrasound-guided transversus abdominis plane block (US-TAP block) administration (preoperative vs. postoperative) affects the perioperative analgesia nociception index (ANI) in adult patients undergoing laparoscopic cholecystectomy. The main questions it aims to answer are:

* Does the timing of the US-TAP block significantly influence intraoperative ANI values? * Does the difference in US-TAP block timing and subsequent ANI values correlate with actual patient recovery, postoperative pain scores (VAS), and complication rates?

If there is a comparison group: Researchers will compare the experimental group (Group A: US-TAP block before surgical incision) to the control group (Group B: US-TAP block after wound closure) to see if early block administration provides superior intraoperative pain suppression and reduces postoperative pain or analgesic consumption.

Participants will:

* Undergo standard general anesthesia induction and maintenance. * Receive a bilateral US-TAP block with a total of 30 mL of 0.2% ropivacaine, administered either before incision (Group A) or after closure (Group B). * Be monitored via standard monitoring devices alongside an ANI monitor. * Use an intravenous patient-controlled analgesia (IV-PCA) pump for 24 hours after surgery. * Participate in postoperative assessments to measure pain scores (VAS), rescue analgesic consumption, satisfaction, and complications at specific intervals up to 24 hours post-surgery.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo laparoscopic cholecystectomy.
  • Aged 19 years or older.
  • American Society of Anesthesiologists (ASA) physical status I, II, or III.

Exclusion criteria

  • Patients who lack the capacity to understand the study examinations or perform the assessment procedures.
  • Patients with coagulation deficiencies or bleeding disorders.
  • Patients with cardiac arrhythmias or those with an implanted cardiac pacemaker.
  • Patients taking medications that affect the autonomic nervous system, including beta-blockers and opioid analgesics.
  • Patients with surgical scars, active lesions, or anatomical abnormalities at the block site.
  • Patients with pre-existing neurological deficits or impairment at the block site.
  • Patients with a known history of allergic reactions or hypersensitivity to ropivacaine or other local anesthetics.
  • Pregnant or lactating individuals.

Treatment and study plan

Preoperative US-TAP Block

Procedure

Ultrasound-guided transversus abdominis plane block administered immediately after general anesthesia induction, prior to surgical incision, using 0.2% ropivacaine (total 30 mL).

Postoperative US-TAP Block

Procedure

Ultrasound-guided transversus abdominis plane block administered after surgical wound closure is completed, before discontinuing inhalation anesthetics, using 0.2% ropivacaine (total 30 mL).

Primary outcomes

  1. Intraoperative Analgesia Nociception Index (ANI)

    Time frame: From anesthesia induction until the end of surgery (approximately 1-2 hours)

Secondary outcomes

  1. Postoperative Pain Intensity via Visual Analogue Scale (VAS)

    Time frame: Up to 24 hours post-surgery (Specifically measured at: upon arrival at the PACU, immediately before PACU discharge, and at 12 and 24 hours post-surgery)

  2. Cumulative Postoperative Rescue Analgesic Consumption

    Time frame: From the end of surgery up to 24 hours post-surgery

  3. Incidence of Postoperative Complications and Adverse Events

    Time frame: From the end of surgery up to 24 hours post-surgery

  4. Patient Satisfaction Score for Postoperative Pain Management

    Time frame: At 24 hours post-surgery

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Comparison of Perioperative Analgesia Nociception Index (ANI) Between Preoperative and Postoperative Ultrasound-guided Transversus Abdominis Plane Block(TAP Block) in Laparoscopic Cholecystectomy

Acronym: CholeANI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

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.

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