Laparoscopic Cholecystectomy, Postoperative Pain
Conditions
Brief 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.
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).
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative Analgesia Nociception Index (ANI) | From anesthesia induction until the end of surgery (approximately 1-2 hours) |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Pain Intensity via Visual Analogue Scale (VAS) | 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 | From the end of surgery up to 24 hours post-surgery |
| Incidence of Postoperative Complications and Adverse Events | From the end of surgery up to 24 hours post-surgery |
| Patient Satisfaction Score for Postoperative Pain Management | At 24 hours post-surgery |
Outcome results
None listed