- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329855
Opioid Consumption After Thoracotomy and Factors Affecting Postoperative Acute Pain
Analysis of Opioid Consumption After Thoracotomy and Factors Affecting Postoperative Acute Pain
Thoracic surgery operations constitute a significant portion of surgical procedures performed in hospitals. In the United States, more than 50,000 thoracic surgical procedures are performed annually, and more than 80% of these patients experience moderate to severe postoperative pain requiring opioid administration, which increases the risk of complications . It has also been reported that chronic pain develops in approximately 50% of patients after thoracic surgery .
Thoracic surgery is commonly associated with severe, multifactorial pain during the postoperative period and is among the surgical branches with a high risk of developing chronic pain Despite advances in understanding postoperative pain mechanisms and improvements in pain management, inadequate postoperative pain control remains an unresolved healthcare problem. Higher acute pain scores are associated with less effective ventilation and coughing, increased incidence of lower respiratory tract infections, and prolonged ICU and hospital stays .
In the management of acute postoperative pain after thoracic surgery, clinicians have sought alternatives to thoracic epidural analgesia to avoid its potential adverse effects. Truncal blocks such as thoracic paravertebral block, erector spinae plane block, and serratus anterior block have been used to reduce postoperative pain . Additionally, various other analgesic techniques such as patient-controlled analgesia (PCA) and multimodal analgesia have been employed. Historically, the cornerstone of acute postoperative pain control has been systemic opioids administered via oral, intravenous, or thoracic epidural routes . Although opioids provide excellent pain relief, they are associated with significant side effects that can adversely affect recovery .
With the increasing use of ultrasonography (USG), truncal blocks have become more widespread. Alongside the development of Enhanced Recovery After Thoracic Surgery (ERATS) protocols, efforts have been made to reduce opioid use, leading to differing opinions regarding the management of acute pain after thoracic surgery. To prevent opioid use disorder and potential side effects, opioid-free or opioid-sparing approaches are now being encouraged in perioperative pain management . Conversely, some studies suggest that intraoperative opioid administration may have favorable effects on postoperative acute and chronic pain. Previous research has reported that the average daily opioid consumption after thoracic surgery is approximately 30 morphine milligram equivalents (MME) .
Although video-assisted thoracoscopic surgery (VATS) has become more common, thoracotomy cases still constitute a large proportion of thoracic surgery procedures. Moreover, severe postoperative pain after thoracic surgery is most commonly associated with the thoracotomy incision itself. While some studies have suggested that new truncal block techniques may provide effective analgesia and reduce opioid consumption after thoracotomy, further studies are needed to determine which blocks are most commonly preferred and how opioid consumption patterns have changed with the adoption of these newer regional techniques.
A review of the current literature reveals that the factors influencing acute pain after thoracotomy have not been sufficiently evaluated. Therefore, a re-evaluation of the factors affecting acute pain following thoracotomy, considering recent developments in pain management, is necessary. Furthermore, examining the relationship between perioperative opioid consumption, postoperative complications, and hospital length of stay in this patient population will provide valuable contributions to the literature.
The aim of this study is to evaluate the amount of opioid consumption following thoracotomy and to investigate whether perioperative opioid use affects acute pain, postoperative complications, and the length of hospital stay.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
H₀ (Null Hypothesis):
Opioid consumption in patients after thoracotomy is not high (≤30 morphine milligram equivalents [MME]/day).
H₁ (Alternative Hypothesis):
Opioid consumption in patients after thoracotomy is high (>30 morphine milligram equivalents [MME]/day).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ziya Can KUŞ
- Phone Number: +905360725382
- Email: ziyacankus2013@gmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged over 18 years
- Patients scheduled for thoracotomy
- Patients with an American Society of Anesthesiologists (ASA) physical status classification of I-III
- Patients who have provided informed consent
- Patients with a body mass index (BMI) between 18-40 kg/m²
Exclusion Criteria:
- Patients with ASA class IV or higher
- Patients younger than 18 years old
- Patients with systemic inflammatory disease
- Patients receiving continuous anti-inflammatory and/or analgesic medication
- Patients with chronic preoperative pain
- Pregnant patients
- Outpatients who received anesthesia outside the operating room
- Emergency cases
- Patients who underwent VATS, sternotomy, mediastinoscopy, or tracheal resection
- Patients with a history of previous thoracic surgery
- Patients who had a thoracic epidural catheter inserted for postoperative pain management
- Patients with a BMI <18 or >40 kg/m²
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients aged over 18 years old scheduled for thoracotomy
The total intraoperative and postoperative opioid consumption will be determined.
The effect of perioperative opioid use on postoperative acute pain, postoperative complications, and length of hospital stay will be investigated.
|
The total intraoperative and postoperative opioid consumption will be determined.
The effect of perioperative opioid use on postoperative acute pain, postoperative complications, and length of hospital stay will be investigated.
Pain levels of patients at 1, 2, 4, 8, 16, 24, and 48 hours after thoracotomy will be evaluated using the Visual Analog Scale (VAS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
opioid consumption
Time Frame: intraoperatively and for 24 hours postoperatively
|
intraoperatively and for 24 hours postoperatively
|
|
Determination of the amount of opioid consumption after thoracotomy
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: ZİYA CAN KUŞ, Ankara Ataturk Sanatorium Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Postoperative Complications
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Central Nervous System Depressants
- Sensory System Agents
- Analgesics
- Narcotics
- Organic Chemicals
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Anilides
- Amides
- Aniline Compounds
- Amines
- Acetanilides
- Central Nervous System Agents
- Acetaminophen
- Analgesics, Opioid
Other Study ID Numbers
- 2024-KAEK-24/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Thoracotomy
-
Menoufia UniversityCompleted
-
University of Maryland, BaltimoreAtriCure, Inc.RecruitingChronic Post-thoracotomy Pain | Post-thoracotomy Pain Syndrome | Acute Post-thoracotomy PainUnited States
-
Yeungnam University College of MedicineUnknownThoracotomyKorea, Republic of
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Yuzuncu Yıl UniversityUnknown
-
Attikon HospitalCompleted
-
Integra LifeSciences CorporationTerminated
-
Denizhan AcarCompletedThoracotomy AnalgesiaTurkey (Türkiye)
-
University Hospital Inselspital, BerneCompletedThoracotomy | SternotomySwitzerland
-
Tanta UniversityCompleted
Clinical Trials on Opioid Analgesic
-
Second Affiliated Hospital, School of Medicine,...CompletedAnkle Sprain | Talus Osteochondral Defect | Non-Opioid Pain Management | Ankle (Ligaments); Instability (Old Injury) | Opioid AnalgesiaChina
-
Rutgers, The State University of New JerseyUniversity of Maryland, Baltimore; University of Michigan; University of Illinois... and other collaboratorsCompleted
-
Asbjørn Mohr DrewesUniversity of Copenhagen; Aleris-Hamlet HospitalUnknown
-
Tokat Gaziosmanpasa UniversityCompleted
-
Istinye UniversityNot yet recruiting
-
Pakistan Kidney and Liver Institute and Research...RecruitingPost Operative Pain | Ureter Stone | UreteroscopyPakistan
-
Virgilio Paolo CarnielliFondazione Cassa di Risparmio di Verona Vicenza Belluno e Ancona; Istituto...UnknownRespiratory Distress Syndrome in Premature Infants
-
University of California, DavisCompletedPleural Effusion | Malignant Pleural EffusionUnited States
-
LinkCare GmbHRuhr University of Bochum; Technical University of Munich; Grünenthal GmbH; Klinikum...Completed
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia