Duloxetine vs Pregabalin for Thoracotomy Pain

Study Overview
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Brief Summary
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This study investigates the effects of preoperative use of oral combination of duloxetine and Pregabalin in comparison with preoperative oral Pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries.

Detailed Description
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75 Patients, undergoing thoracotomy surgery will be randomly allocated into three equal groups, each (n=25 ), using computerized generated random tables: Group P: will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. Group D:will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . Group C: will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week. The total amount of morphine consumption in the first 24 hours postoperatively, total amount of intraoperative fentanyl will be recorded, change in hemodynamics ((heart rate and mean arterial blood pressure), respiratory rate and oxygen saturation will be monitored and recorded at 0,2, 4, 8, 12 ,16 &24 hours and Visual analogue scale at 0, 2,4, 8, 12, 16 &24 hours postoperatively then at 3rd, 5th days, 4th week and12th week will be measured.

Official Title
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Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ● Physical status ASA II, III. Age ≥ 18 and ≤ 65 Years. Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2. Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or metastatectomy from the lung. Patient is able to provide a written informed consent. Exclusion Criteria: ● Patients with Known sensitivity or contraindication to drug used in the study History of psychological disorders and/or chronic pain. Previous administration of antidepressants, anticonvulsants, or opioids before surgery. Patient refusal. Severe respiratory or cardiac disorders. Advanced liver or kidney disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Pregabalin<br>Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. | Drug: Pregabalin<br>* Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.<br>|
| Experimental: Group Duloxetine<br>Patients will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . | Drug: Duloxetine<br>* Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .<br>|
| Experimental: Group Pregabalin& Duloxetine<br>Patients will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week. | Drug: Pregabalin<br>* Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.<br>Drug: Duloxetine<br>* Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | 12 weeks | 
| Total dose of intraoperative fentanyl. | The total dose of intraoperative fentanyle administration rather than the dose used in induction | 2 hours intraoperative | 
| Heart rate | Heart rate will be measured preoperative as baseline value, intraoperative and postoperative | 24 hours | 
| Mean arterial pressure | Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative. | 24 hours postoperative |