Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery

Study Overview
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Brief Summary
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Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery

Detailed Description
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Thoracotomy is one of the most painful surgical procedures known, and severe pain is encountered in 21-67% of patients after thoracotomy. The most important causes of this pain arise from the bone structures of the thoracic wall, damage to the costal joint junctions, stretching of the ligaments, rib fractures, and damage to the intercostal nerve and major muscles. Another factor that causes pain after thoracotomy is the chest tubes placed in the thorax to provide drainage (1). As a result of this pain caused by loss of tissue and pulmonary reserve, effective coughing and decreased chest expansion can lead to serious complications such as atelectasis, ventilation/perfusion mismatch, hypoxemia, immobilization, thromboembolism and infection. These complications are associated with increased morbidity and mortality in thoracic surgery (2). Ensuring pain management in patients undergoing thoracotomy is important in terms of reducing postoperative complications, ensuring early mobilization and increasing patient comfort. Since there is no single source that causes pain after thoracotomy, pain must be controlled at all levels. For this reason, a multimodal approach using pharmacological and non-pharmacological techniques is preferred in analgesia after thoracotomy. This approach reduces drug side effects along with the consumption of analgesics. Opioids and nonsteroidal anti-inflammatory drugs are used in pharmacological analgesia. In our study, the investigators aim to compare the effects of tramadol, pethidine and morphine using intravenous patient-controlled analgesia in the treatment of postoperative pain in elective thoracic surgery.

Official Title
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Comparison of the Analgesic Effects of Tramadol, Pethidine and Morphine Under Erector Spinae Plane (ESP) Block in the Treatment of Pain After Elective Thoracic Surgery

Conditions
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Thoracic Diseases, Analgesia

Intervention / Treatment
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* Drug: Tramadol hydrochloride
* Drug: Aldolan
* Drug: Morphine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having non-urgent thoracic surgery over 18 years old Being in group I-III according to the American Society of Anesthesiologists (ASA) classification Not have allergies to the drugs to be used (volunteers with diseases that prevent the use of drugs will not be included in the study regardless of gender Exclusion Criteria: . Have allergies to the drugs to be used

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 groups of patients are received different type of analgesics
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol<br>Tramadol receiving group | Drug: Tramadol hydrochloride<br>* Patients are receiving tramadol hydrochloride under thoracic surgery<br>|
| Active Comparator: Aldolan<br>Aldolan receiving group | Drug: Aldolan<br>* Patients are receiving meperidine under thoracic surgery<br>|
| Active Comparator: Morphine<br>Morphine receiving group | Drug: Morphine hydrochloride<br>* Patients are receiving Morphine hydrochloride under thoracic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of drugs's analgesic effects | To compare the analgesic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be assesed with numeric rating scale ( 0= no pain, 10= worst pain imaginable) | postoperative 24 hours | 
| Comparing hemodynamic effects | To compare hemodynamic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be asssesed with measurements of intraoperative values of systolic, diastolic and mean arterial blood pressure | Intraoperatively, then postoperative 24 hours | 
| Comparing respiratory effects | To compare respiratory effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery. It will be asssesed with postoperative pulmonary complications such as failed extubation, bronchospasms or respiratory depressions. | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of analgesics | It was aimed to compare the effects of drugs in terms of side effects, early mobilization. | postoperative 24 hours | 
| surgeon satisfaction | With a questionnaire, surgeon satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree) | Immediately after the surgery | 
| patient satisfaction | With a questionnaire, patient satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree) When Aldrete score> 8, patient will be questioned for satisfaction. | Postoperative 30th minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care, thoracic surgery, patient controlled analgesia, postoperative care unit