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

NCT ID: NCT06172920

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-12-09

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.

Conditions

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Thoracic Diseases Analgesia

Keywords

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thoracic surgery patient controlled analgesia postoperative care unit intensive care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups of patients are received different type of analgesics
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Double blind

Study Groups

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Tramadol

Tramadol receiving group

Group Type ACTIVE_COMPARATOR

Tramadol hydrochloride

Intervention Type DRUG

Patients are receiving tramadol hydrochloride under thoracic surgery

Aldolan

Aldolan receiving group

Group Type ACTIVE_COMPARATOR

Aldolan

Intervention Type DRUG

Patients are receiving meperidine under thoracic surgery

Morphine

Morphine receiving group

Group Type ACTIVE_COMPARATOR

Morphine hydrochloride

Intervention Type DRUG

Patients are receiving Morphine hydrochloride under thoracic surgery

Interventions

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Tramadol hydrochloride

Patients are receiving tramadol hydrochloride under thoracic surgery

Intervention Type DRUG

Aldolan

Patients are receiving meperidine under thoracic surgery

Intervention Type DRUG

Morphine hydrochloride

Patients are receiving Morphine hydrochloride under thoracic surgery

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Begüm Nemika Gökdemir

Begüm Nemika Gökdemir, Research Assistant of Anesthesiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Begum N Gokdemir, MD

Role: CONTACT

Phone: 03122036868

Email: [email protected]

Facility Contacts

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Adnan Torgay, Professor;MD

Role: primary

Other Identifiers

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KA23/137

Identifier Type: -

Identifier Source: org_study_id