Prediction of Postoperative Pain Using Venous Cannulation Pain and Preoperative Anxiety Scores
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: APAIS Assessment.
- Who it may be relevant to
- Registry conditions: Preoperative Anxiety, Postoperative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association of Venous Cannulation Pain and Preoperative Anxiety (APAIS) With Postoperative Pain Following Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
Overview
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.
Detailed description
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.
Interventions
- Other APAIS Assessment
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).
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Total Analgesic Consumption [Time frame: First 12 hours after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07451925 · IVLINEVAS