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Duloxetine vs Pregabalin for Thoracotomy Pain

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ClinicalTrials.gov Identifier: NCT04782310
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Bassant M. Abdelhamid, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Pregabalin Drug: Duloxetine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : August 10, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group Pregabalin
Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
 Drug: Pregabalin
Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Experimental: Group Duloxetine
Patients will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
 Drug: Duloxetine
Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
Experimental: 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.
 Drug: Pregabalin
Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.

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


Outcome Measures
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Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 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 :
  1. Visual analogue scale [ Time Frame: 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.

  2. Total dose of intraoperative fentanyl. [ Time Frame: 2 hours intraoperative ]
    The total dose of intraoperative fentanyle administration rather than the dose used in induction

  3. Heart rate [ Time Frame: 24 hours ]
    Heart rate will be measured preoperative as baseline value, intraoperative and postoperative

  4. Mean arterial pressure [ Time Frame: 24 hours postoperative ]
    Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782310


Contacts
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Contact: Bassant Abdelhamid 01224254012 bassantmohamed197@yahoo.com
Contact: Mary Sabry marysabry136@gmail.com

Locations
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Egypt
Bassant abdelhamid Recruiting
Cairo, Egypt, 1772
Contact: Bassant abdelhamid    01224254012    bassantmohamed197@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Bassant abdelhamid Cairo University
More Information
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Publications:

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Responsible Party: Bassant M. Abdelhamid, Associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT04782310    
Other Study ID Numbers: MS-386-2020
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pregabalin
Duloxetine Hydrochloride
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents