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

NCT07451925 | Not Yet Recruiting

• 1 other identifier: IVLINEVAS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preoperative Anxiety; Postoperative Pain

Keywords

APAIS; postoperative pain; preoperative anxiety; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Early Postoperative Pain Intensity

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

  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)

Secondary Outcomes (1)

• Total Analgesic Consumption

  First 12 hours after surgery

Study Arms (1)

Patients Undergoing Elective Laparoscopic Cholecystectomy

Adult patients (≥18 years) classified as ASA physical status 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. All participants will undergo standardized anesthesia and postoperative analgesia according to institutional protocols.

Other: APAIS Assessment

Interventions

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).

Also known as: Venous Cannulation Pain Assessment

Patients Undergoing Elective Laparoscopic Cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients undergoing elective laparoscopic cholecystectomy under standardized general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Arsen Gungor Ay, specialist

CONTACT

+905534948426; arsen.gungor@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesia and Reanimation

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 5, 2026
• Study Start: March 2, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03