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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06172920
Other study ID # KA23/137
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date December 31, 2023
Est. completion date December 9, 2024

Study information

Verified date December 2023
Source Baskent University
Contact Begum N Gokdemir, MD
Phone 03122036868
Email begokdemir@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date December 9, 2024
Est. primary completion date November 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tramadol hydrochloride
Patients are receiving tramadol hydrochloride under thoracic surgery
Aldolan
Patients are receiving meperidine under thoracic surgery
Morphine hydrochloride
Patients are receiving Morphine hydrochloride under thoracic surgery

Locations

Country Name City State
Turkey Baskent University Ankara Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Adverse effects of analgesics It was aimed to compare the effects of drugs in terms of side effects, early mobilization. postoperative 24 hours
Secondary surgeon satisfaction With a questionnaire, surgeon satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree) Immediately after the surgery
Secondary 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
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