ClinicalTrials.gg
Not yet recruitingNCT07809009CholeANIUpdated Sep 9, 2026

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

An interventional study of Preoperative US-TAP Block and Postoperative US-TAP Block in Laparoscopic Cholecystectomy and Postoperative Pain, sponsored by Pusan National University Yangsan Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Laparoscopic Cholecystectomy
  • Postoperative Pain

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03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 120 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 108 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 to ropivacaine or other local anesthetics.
  • Pregnant or lactating individuals.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Group A: Preoperative US-TAP Block

    Patients receiving ultrasound-guided transversus abdominis plane block immediately after general anesthesia induction, prior to surgical incision.

    Procedure: Preoperative US-TAP Block

  • Active comparator
    Group B: Postoperative US-TAP Block

    Patients receiving ultrasound-guided transversus abdominis plane block after surgical wound closure is completed, before discontinuing inhalation anesthetics.

    Procedure: Postoperative US-TAP Block

Interventions

  • ProcedurePreoperative US-TAP Block

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

  • ProcedurePostoperative US-TAP Block

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07809009
Responsible party
Hyeon-soo Park (Assistant Professor, Department of Anesthesiology and Pain Medicine, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Sep 9, 2026
Start date
Aug 31, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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