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

March 4, 2026 updated by: Arsen Gungor Ay, Fatih Sultan Mehmet Training and Research Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
First 12 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IVLINEVAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The final decision regarding individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be established following completion of the study and publication of the primary results, in accordance with institutional regulations and ethical considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on APAIS Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings