- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06838897
Preoperative Pain Catastrophizing and Intraoperative Analgesia Consumption
July 22, 2025 updated by: Ahmet Pece
Association Between Preoperative Pain Catastrophizing Scale and Intraoperative Analgesia Consumption in Elective Laparoscopic Cholecystectomy
This observational study aims to evaluate the relationship between the Pain Catastrophizing Scale (PCS) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy.
During the preoperative period, patients will complete the Pain Catastrophizing Scale, the Beck Depression Inventory, and the Beck Anxiety Scale.
During the intraoperative period, analgesia nociceptive index (ANI) electrodes will be placed, and remifentanil dosing will be adjusted accordingly.
The correlation between preoperative Pain Catastrophizing Scale scores and intraoperative remifentanil consumption will be analyzed.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ilkadım
-
Samsun, Ilkadım, Turkey, 55100
- Samsun Üniversitesi Eğitim Ve Araştırma Hastanesi
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients scheduled for elective laparoscopic cholecystectomy.
Description
Inclusion Criteria:
- Patients with ASA scores of I-III
- Patients with Turkish literacy skills.
- Patients scheduled for elective laparoscopic cholecystectomy.
Exclusion Criteria:
- Patients unwillingness to participate in the study.
- Conversion of surgery from laparoscopic to open surgery.
- Patients undergoing emergency laparoscopic cholecystectomy.
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 |
|---|
|
Patients undergoing laparoscopic cholecystectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative remifentanyl requirement
Time Frame: Intraoperative period
|
The main purpose of this study is to evaluate the correlation between preoperative Pain Catastrophizing Scale and intraoperative analgesia consumption.Intraoperative analgesic dose is adjusted according to the analgesia nociceptive index.
|
Intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale for postoperative pain intensity
Time Frame: up to 24 hours
|
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals.
NRS is a unidimensional measure of pain intensity in adults.
The NRS is a segmented numeric version of the visual analog scale in which a respondent selectsand its correlation with the preoperative PCS score will be investigated.
|
up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 11, 2025
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
July 7, 2025
Study Registration Dates
First Submitted
February 16, 2025
First Submitted That Met QC Criteria
February 16, 2025
First Posted (Actual)
February 21, 2025
Study Record Updates
Last Update Posted (Actual)
July 23, 2025
Last Update Submitted That Met QC Criteria
July 22, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ceyla kolesistektomi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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