NCT05177575

Brief Summary

Thoracotomy is frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe 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 thoracotomy pain in the later period, and may adversely affect the quality of life of the patients. This study aims to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracotomy.

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

Typical duration 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

First Submitted

Initial submission to the registry

December 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 16, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

December 16, 2021

Last Update Submit

August 28, 2023

Conditions

Keywords

Postoperative PainPostoperative Pain, AcutePostoperative Pain, ChronicThoracotomy

Outcome Measures

Primary Outcomes (2)

  • Chronic pain symptoms 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.

  • Chronic pain symptoms at 6th 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 6th month after surgery.

    Chronic pain symptoms at 6th months.

Interventions

The chronic pain findings of the patients who underwent thoracotomy will be questioned at the postoperative 3rd and 6th 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 thoracotomy will be included in the 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 (BMI) between 18-35 kg/m2
  • Patients undergoing elective thoracotomy

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, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Musa Zengin, MD

    Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Musa Zengin, MD

CONTACT

Ali Alagoz, Assoc Prof

CONTACT

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 16, 2021

First Posted

January 4, 2022

Study Start

December 16, 2021

Primary Completion

March 16, 2024

Study Completion

April 16, 2024

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations