Laparoscopic CholecystectomyCholeANINCT07809009
Comparison of ANI Between Preoperative and Postoperative Ultrasound-guided TAP Block in Laparoscopic Cholecystectomy
A study testing Preoperative US-TAP Block and Postoperative US-TAP Block in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Pusan National University Yangsan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain
- What is being tested?
- Preoperative US-TAP Block and Postoperative US-TAP Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo laparoscopic cholecystectomy.
- Aged 19 years or older.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
Who cannot join
- 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.
About this study
Official title: Comparison of Perioperative Analgesia Nociception Index (ANI) Between Preoperative and Postoperative Ultrasound-guided Transversus Abdominis Plane Block(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?
Read more
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.
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain
- Being tested
- Preoperative US-TAP Block, Postoperative US-TAP Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative US-TAP BlockProcedure or surgery
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 BlockProcedure or surgery
Ultrasound-guided transversus abdominis plane block administered after surgical wound closure is completed, before discontinuing inhalation anesthetics, using 0.2% ropivacaine (total 30 mL).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Preoperative US-TAP Block | Experimental | Patients receiving ultrasound-guided transversus abdominis plane block immediately after general anesthesia induction, prior to surgical incision. Receives: Procedure: Preoperative US-TAP Block |
| Group B: Postoperative US-TAP Block | Active comparator | Patients receiving ultrasound-guided transversus abdominis plane block after surgical wound closure is completed, before discontinuing inhalation anesthetics. Receives: Procedure: Postoperative US-TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Analgesia Nociception Index (ANI)
Measured: From anesthesia induction until the end of surgery (approximately 1-2 hours)
Secondary outcomes (4)
Postoperative Pain Intensity via Visual Analogue Scale (VAS)
Measured: 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)
Cumulative Postoperative Rescue Analgesic Consumption
Measured: From the end of surgery up to 24 hours post-surgery
Incidence of Postoperative Complications and Adverse Events
Measured: From the end of surgery up to 24 hours post-surgery
Patient Satisfaction Score for Postoperative Pain Management
Measured: At 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-soo Park, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809009
- Sponsor's protocol ID
- 11-2026-023
- Acronym
- CholeANI
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Analgesia Nociception Index (ANI) Between Preoperative and Postoperative Ultrasound-guided Transversus Abdominis Plane Block(TAP Block) in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07809009
- Acronym / sponsor ID
- CholeANI / 11-2026-023
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Preoperative US-TAP Block | Experimental | Procedure: Preoperative US-TAP BlockPatients receiving ultrasound-guided transversus abdominis plane block immediately after general anesthesia induction, prior to surgical incision. |
| Group B: Postoperative US-TAP Block | Active comparator | Procedure: Postoperative US-TAP BlockPatients receiving ultrasound-guided transversus abdominis plane block after surgical wound closure is completed, before discontinuing inhalation anesthetics. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo laparoscopic cholecystectomy.
- Aged 19 years or older.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative US-TAP BlockUltrasound-guided transversus abdominis plane block administered immediately after general anesthesia induction, prior to surgical incision, using 0.2% ropivacaine (total 30 mL). | Procedure or surgery | Group A: Preoperative US-TAP Block |
| Postoperative US-TAP BlockUltrasound-guided transversus abdominis plane block administered after surgical wound closure is completed, before discontinuing inhalation anesthetics, using 0.2% ropivacaine (total 30 mL). | Procedure or surgery | Group B: Postoperative US-TAP Block |
Primary outcome
Intraoperative Analgesia Nociception Index (ANI)
Time frame: From anesthesia induction until the end of surgery (approximately 1-2 hours)
4 secondary outcomes
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)
Cumulative Postoperative Rescue Analgesic Consumption
Time frame: From the end of surgery up to 24 hours post-surgery
Incidence of Postoperative Complications and Adverse Events
Time frame: From the end of surgery up to 24 hours post-surgery
Patient Satisfaction Score for Postoperative Pain Management
Time frame: At 24 hours post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative US-TAP Block and Postoperative US-TAP Block in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Pusan National University Yangsan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Analgesia Nociception Index (ANI) (time frame: From anesthesia induction until the end of surgery (approximately 1-2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.