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

Phase 4

Not yet recruiting

• Conditions: Analgesia; Thoracic Diseases
• Interventions: Drug: Morphine hydrochloride; Drug: Aldolan; Drug: Tramadol hydrochloride

• Registration Number: NCT06172920
• Lead Sponsor: Baskent University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-10
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Study Start: 2023-12-31
• Primary Completion: 2024-11-09
• Study Completion: 2024-12-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine hydrochloride	Morphine receiving group
Aldolan	Aldolan	Aldolan receiving group
Tramadol	Tramadol hydrochloride	Tramadol receiving group

Primary Outcome Measures

Name	Time	Method
Comparing hemodynamic effects	Intraoperatively, then postoperative 24 hours	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
Comparing respiratory effects	postoperative 24 hours	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.
The rate of drugs's analgesic effects	postoperative 24 hours	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)

Secondary Outcome Measures

Name	Time	Method
surgeon satisfaction	Immediately after the surgery	With a questionnaire, surgeon satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree)
Adverse effects of analgesics	postoperative 24 hours	It was aimed to compare the effects of drugs in terms of side effects, early mobilization.
patient satisfaction	Postoperative 30th minute	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.

Trial Locations

Locations (1)

Baskent University Ankara Hospital; 🇹🇷 Ankara, Turkey