NCT05187390

Brief Summary

Video-assisted thoracic surgery (VATS) is frequently performed in thoracic surgery. It is widely accepted that VATS causes acute pain. Many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. This acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic pain in the later period, and may adversely affect the quality of life of the patients. This study, it was aimed to analyze the symptoms of chronic pain in the 1st and 3rd months postoperatively in patients who had undergone VATS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 14, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 24, 2021

Last Update Submit

December 24, 2021

Conditions

Keywords

Postoperative PainPostoperative Pain, AcutePostoperative Pain, ChronicVATS

Outcome Measures

Primary Outcomes (2)

  • Pain scores at 1st months.

    Chronic pain symptoms will be assessed using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, electric shock-like pain, tingling, numbness, pins, and needles feeling, hyperalgesia, allodynia, and hypoesthesia) will also be asked to the patients in the 1st month after surgery.

    Chronic pain symptoms at 1st months

  • Pain scores at 3rd months

    Chronic pain symptoms will be assessed using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, electric shock-like pain, tingling, numbness, pins, and needles feeling, hyperalgesia, allodynia, and hypoesthesia) will also be asked to the patients in the 3rd month after surgery.

    Chronic pain symptoms at 3rd months

Interventions

The chronic pain findings of the patients who underwent VATS will be questioned at the postoperative 1st and 3rd months.

Eligibility Criteria

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

Patients between the ages of 18-65 years, in the ASA I-II-III risk group, with a BMI between 18-35 kg/m2 and undergoing VATS will be included in our study. Patients under the age of 18 years and over the age of 65 years, with an ASA score of IV and above, with a BMI below 18 kg/m2 and above 35 kg/m2, who were operated under emergency conditions, and who received chronic pain treatment will be excluded from the study.

You may qualify if:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-35 kg/m2
  • Patients undergoing elective VATS

You may not qualify if:

  • Advanced cancer
  • History of chronic analgesic therapy
  • Patients with previous thoracic surgery
  • Patients who were operated under emergency conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06290, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Oya Kaybal, MD

    Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

December 24, 2021

First Posted

January 11, 2022

Study Start

December 14, 2021

Primary Completion

June 14, 2022

Study Completion

July 14, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations