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NCT Number: NCT07451925

Prediction of Postoperative Pain Using Venous Cannulation Pain and Preoperative Anxiety Scores

Postoperative pain remains a significant clinical problem affecting recovery, mobilization, and patient satisfaction after surgery. Considerable interindividual variability exists in postoperative pain intensity even among patients undergoing the same surgical procedure. This variability may be influenced not only by the extent of surgical trauma but also by individual pain sensitivity and psychological factors such as preoperative anxiety.

The aim of this prospective observational study is to evaluate whether pain intensity reported during routine venous cannulation and preoperative anxiety levels assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) can predict early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Venous cannulation pain will be assessed using a 0-10 visual analog scale (VAS), and anxiety levels will be measured preoperatively using APAIS. Postoperative pain will be evaluated at predefined time points within the first 12 hours after surgery using VAS scores and analgesic consumption. Identifying simple and easily obtainable preoperative predictors may allow individualized postoperative analgesic strategies for patients at higher risk of severe postoperative pain.

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Key information

About this study

Postoperative pain is a common and clinically relevant problem that negatively affects recovery, early mobilization, patient satisfaction, and overall surgical outcomes. Despite standardized anesthetic and analgesic protocols, significant interindividual variability exists in postoperative pain intensity among patients undergoing the same surgical procedure. This variability may be influenced not only by surgical factors but also by individual pain sensitivity and psychological characteristics, particularly preoperative anxiety.

Pain experienced during routine preoperative procedures such as venous cannulation may reflect individual pain sensitivity and central pain processing mechanisms. Similarly, elevated preoperative anxiety levels have been associated with increased postoperative pain intensity and higher analgesic requirements. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a validated instrument widely used to quantify preoperative anxiety.

This prospective observational study aims to investigate the predictive value of pain reported during venous cannulation and preoperative anxiety levels assessed by APAIS on early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

After obtaining ethics committee approval and written informed consent, adult patients (≥18 years) classified as ASA I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded.

Preoperative anxiety will be assessed using APAIS prior to transfer to the operating room. Venous cannulation will be performed routinely with a 20G intravenous catheter on the dorsum of the hand by an experienced practitioner. Pain intensity during cannulation will be assessed using a 0-10 visual analog scale (VAS).

All patients will receive standardized general anesthesia and postoperative analgesia according to institutional protocols. Postoperative pain intensity will be evaluated using VAS at predefined time points: upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively. Rescue analgesia and total analgesic consumption during the first 12 hours will be recorded.

Statistical analysis will evaluate correlations between venous cannulation pain, APAIS scores, and postoperative VAS scores. Multivariable regression analysis will be performed to identify independent predictors of postoperative pain intensity.

By identifying simple and easily obtainable preoperative indicators of postoperative pain risk, this study aims to contribute to individualized analgesic strategies and improved perioperative pain management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Ability to understand and use the Visual Analog Scale (VAS)
  • Ability to complete the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
  • Provision of written informed consent

Exclusion criteria

  • Emergency surgery
  • Conversion from laparoscopic to open surgery
  • Cognitive impairment or inability to communicate effectively
  • Chronic pain lasting longer than 3 months
  • More than three venous cannulation attempts
  • Surgical duration exceeding 2 hours
  • Refusal to participate

Treatment and study plan

APAIS Assessment

Other

Preoperative anxiety is evaluated using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).Pain during routine venous cannulation is assessed using a 0-10 visual analog scale (VAS).

Other names: Venous Cannulation Pain Assessment

Primary outcomes

  1. Early Postoperative Pain Intensity

    Time frame: Within the first 12 hours after surgery (upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively)

    Postoperative pain intensity assessed using a 0-10 visual analog scale (VAS).

Secondary outcomes

  1. Total Analgesic Consumption

    Time frame: First 12 hours after surgery

    Total amount of analgesic medications administered during the first 12 postoperative hours, including rescue analgesics.

Study contacts

Contact information is provided by the study sponsor or research team.

Arsen Gungor Ay, specialist

CONTACT

[email protected]

+905534948426

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

Association of Venous Cannulation Pain and Preoperative Anxiety (APAIS) With Postoperative Pain Following Elective Laparoscopic Cholecystectomy: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 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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