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

December 13, 2023 updated by: Begüm Nemika Gökdemir, Baskent University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Baskent University Ankara Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tramadol
Tramadol receiving group
Drug: Tramadol hydrochloride
Patients are receiving tramadol hydrochloride under thoracic surgery
Active Comparator: Aldolan
Aldolan receiving group
Drug: Aldolan
Patients are receiving meperidine under thoracic surgery
Active Comparator: Morphine
Morphine receiving group
Drug: Morphine hydrochloride
Patients are receiving Morphine hydrochloride under thoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
postoperative 24 hours
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
Intraoperatively, then postoperative 24 hours
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.
postoperative 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2023

Primary Completion (Estimated)

November 9, 2024

Study Completion (Estimated)

December 9, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA23/137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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