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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Pregabalin | Experimental | Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. |
|
| Group Duloxetine | Experimental | Patients will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . |
|
| Group Pregabalin& Duloxetine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day. |
|
| 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 |
| 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. |
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Inclusion Criteria:
● Physical status ASA II, III.
Exclusion Criteria:
● Patients with Known sensitivity or contraindication to drug used in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bassant Abdelhamid | Contact | 01224254012 | bassantmohamed197@yahoo.com | |
| Mary Sabry | Contact | marysabry136@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bassant abdelhamid | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bassant abdelhamid | Recruiting | Cairo | 1772 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30020088 | Background | Altiparmak B, Guzel C, Gumus Demirbilek S. Comparison of Preoperative Administration of Pregabalin and Duloxetine on Cognitive Functions and Pain Management After Spinal Surgery: A Randomized, Double-blind, Placebo-controlled Study. Clin J Pain. 2018 Dec;34(12):1114-1120. doi: 10.1097/AJP.0000000000000640. | |
| 26982602 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Duloxetine | Drug | Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast . |
|
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 |
| Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, DuMerton-Shore D, Walker S. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016 Jul;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |