Postoperative Pain
Conditions
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.
Interventions
DRUGPregabalin
Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
DRUGDuloxetine
Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | 24 hours postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | 12 weeks | 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. |
| Total dose of intraoperative fentanyl. | 2 hours intraoperative | The total dose of intraoperative fentanyle administration rather than the dose used in induction |
| Heart rate | 24 hours | Heart rate will be measured preoperative as baseline value, intraoperative and postoperative |
| Mean arterial pressure | 24 hours postoperative | Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative. |
Countries
Egypt
Contacts
Backup ContactMary Sabry
Primary ContactBassant Abdelhamid
Outcome results
None listed