NCT06838897

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

February 16, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

pain

Outcome Measures

Primary Outcomes (1)

  • Intraoperative remifentanyl requirement

    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 Outcomes (1)

  • Numeric rating scale for postoperative pain intensity

    up to 24 hours

Study Arms (1)

Patients undergoing laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective laparoscopic cholecystectomy.

You may qualify if:

  • Patients with ASA scores of I-III
  • Patients with Turkish literacy skills.
  • Patients scheduled for elective laparoscopic cholecystectomy.

You may not qualify if:

  • Patients unwillingness to participate in the study.
  • Conversion of surgery from laparoscopic to open surgery.
  • Patients undergoing emergency laparoscopic cholecystectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Üniversitesi Eğitim Ve Araştırma Hastanesi

Samsun, ilkadım, 55100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 21, 2025

Study Start

April 11, 2025

Primary Completion

June 30, 2025

Study Completion

July 7, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations