Clinical trial NCT04782310: Duloxetine vs Pregabalin for Thoracotomy Pain
Official title: Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 12 weeks
measure: Total dose of intraoperative fentanyl.
timeFrame: 2 hours intraoperative
measure: Heart rate
timeFrame: 24 hours
measure: Mean arterial pressure
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Bassant abdelhamid
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.