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Clinical Trials/NCT06172920
NCT06172920Not yet recruitingPhase 4

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

Baskent University1 site in 1 country45 target enrollmentStarted: December 31, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
45
Locations
1
Primary Endpoint
Comparing hemodynamic effects

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Masking Description

Double blind

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Morphine

Active Comparator

Morphine receiving group

Intervention: Morphine hydrochloride (Drug)

Tramadol

Active Comparator

Tramadol receiving group

Intervention: Tramadol hydrochloride (Drug)

Aldolan

Active Comparator

Aldolan receiving group

Intervention: Aldolan (Drug)

Outcomes

Primary Outcomes

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.

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)

Secondary Outcomes

  • surgeon satisfaction(Immediately after the surgery)
  • Adverse effects of analgesics(postoperative 24 hours)
  • patient satisfaction(Postoperative 30th minute)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Begüm Nemika Gökdemir

Begüm Nemika Gökdemir, Research Assistant of Anesthesiology Department

Baskent University

Study Sites (1)

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