Duloxetine vs Pregabalin for Thoracotomy Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782310
• Other study ID #: MS-386-2020
• Status: Recruiting
• Phase: Phase 4
• Start date: March 10, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: Bassant Abdelhamid
• Phone: 01224254012
• Email: bassantmohamed197[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 15, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin
Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
• Duloxetine
Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .

Locations

Country	Name	City	State
Egypt	Bassant abdelhamid	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Altiparmak B, Güzel Ç, Gümüs 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total dose of intraoperative fentanyl.	The total dose of intraoperative fentanyle administration rather than the dose used in induction	2 hours intraoperative
Secondary	Heart rate	Heart rate will be measured preoperative as baseline value, intraoperative and postoperative	24 hours
Secondary	Mean arterial pressure	Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative.	24 hours postoperative