Duloxetine vs Pregabalin for Thoracotomy Pain

Phase 4

• Conditions: Postoperative Pain
• Interventions: Drug: Pregabalin; Drug: Duloxetine

• Registration Number: NCT04782310
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-03-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02
• Primary Completion: 2021-08-10
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Pregabalin	Pregabalin	Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Group Duloxetine	Duloxetine	Patients will receive oral duloxetine 30mg two hour preoperatively ...will be continued for one week once per day after breakfast .
Group Pregabalin& Duloxetine	Pregabalin	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.
Group Pregabalin& Duloxetine	Duloxetine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bassant abdelhamid; 🇪🇬 Cairo, Egypt