Duloxetine vs Pregabalin for Thoracotomy Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Pregabalin

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

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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

Group Duloxetine

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

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .

Group Pregabalin& 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.

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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

Duloxetine

Intervention Type DRUG

Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .

Interventions

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Pregabalin

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

Intervention Type DRUG

Duloxetine

Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No