Thoracic DiseasesPhase 4NCT06172920
Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery
A Phase 4 study testing Tramadol hydrochloride, Aldolan and Morphine hydrochloride in people with Thoracic Diseases and Analgesia, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Diseases, Analgesia
- What is being tested?
- Tramadol hydrochloride, Aldolan and Morphine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2023to 9 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- . Have allergies to the drugs to be used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara
Adnan Torgay, Professor;MD, +905307384682, atorgay@gmail.com
About this study
Official title: 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
Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery
Read the 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.
- Conditions
- Thoracic Diseases, Analgesia
- Being tested
- Tramadol hydrochloride, Aldolan, Morphine hydrochloride
- Keywords
- thoracic surgery, patient controlled analgesia, postoperative care unit, intensive care
- Medical subject headings
- Thoracic Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochlorideDrug
Patients are receiving tramadol hydrochloride under thoracic surgery
AldolanDrug
Patients are receiving meperidine under thoracic surgery
Morphine hydrochlorideDrug
Patients are receiving Morphine hydrochloride under thoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Active comparator | Tramadol receiving group Receives: Drug: Tramadol hydrochloride |
| Aldolan | Active comparator | Aldolan receiving group Receives: Drug: Aldolan |
| Morphine | Active comparator | Morphine receiving group Receives: Drug: Morphine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: postoperative 24 hours
Secondary outcomes (3)
Adverse effects of analgesics
It was aimed to compare the effects of drugs in terms of side effects, early mobilization.
Measured: postoperative 24 hours
surgeon satisfaction
With a questionnaire, surgeon satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree)
Measured: 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.
Measured: Postoperative 30th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start31 Dec 2023 (estimated)
- Primary completion9 Nov 2024 (estimated)
- Study completion9 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of patients are received different type of analgesics
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm Nemika Gökdemir, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172920
- Sponsor's protocol ID
- KA23/137
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06172920
- Acronym / sponsor ID
- KA23/137
- Conditions
- Thoracic Diseases, Analgesia
- Keywords
- thoracic surgery, patient controlled analgesia, postoperative care unit, intensive care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 9 Nov 2024 (estimated)
- Study completion
- 9 Dec 2024 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 3 groups of patients are received different type of analgesics
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Active comparator | Drug: Tramadol hydrochlorideTramadol receiving group |
| Aldolan | Active comparator | Drug: AldolanAldolan receiving group |
| Morphine | Active comparator | Drug: Morphine hydrochlorideMorphine receiving group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- . Have allergies to the drugs to be used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol hydrochloridePatients are receiving tramadol hydrochloride under thoracic surgery | Drug | Tramadol |
| AldolanPatients are receiving meperidine under thoracic surgery | Drug | Aldolan |
| Morphine hydrochloridePatients are receiving Morphine hydrochloride under thoracic surgery | Drug | Morphine |
Primary outcome
The rate of drugs's analgesic effects
Time frame: 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)
Comparing hemodynamic effects
Time frame: 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
Time frame: 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.
3 secondary outcomes
Adverse effects of analgesics
Time frame: postoperative 24 hours
surgeon satisfaction
Time frame: Immediately after the surgery
patient satisfaction
Time frame: Postoperative 30th minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol hydrochloride, Aldolan and Morphine hydrochloride in people with Thoracic Diseases and Analgesia, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begum N Gokdemir, MD (03122036868, begokdemir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of drugs's analgesic effects (time frame: postoperative 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.