Duloxetine vs Pregabalin for Thoracotomy Pain

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Pregabalin; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT04782310

MS-386-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

Group Pregabalin

Experimental group

Description:

Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.

Treatment:

Drug: Pregabalin

Group Duloxetine

Experimental group

Description:

Patients will receive oral duloxetine 30mg two hour preoperatively ...will be continued for one week once per day after breakfast .

Treatment:

Drug: Duloxetine

Group Pregabalin& Duloxetine

Experimental group

Description:

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.

Treatment:

Drug: Duloxetine

Drug: Pregabalin