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Duloxetine vs Pregabalin for Thoracotomy Pain

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin
Duloxetine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bassant abdelhamidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group Pregabalin

Group Duloxetine

Group Pregabalin& Duloxetine

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Visual analogue scale
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

Visual analogue scale
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.
The total dose of intraoperative fentanyle administration rather than the dose used in induction
Heart rate
Heart rate will be measured preoperative as baseline value, intraoperative and postoperative
Mean arterial pressure
Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative.

Full Information

First Posted
March 1, 2021
Last Updated
May 31, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04782310
Brief Title
Duloxetine vs Pregabalin for Thoracotomy Pain
Official Title
Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Pregabalin
Arm Type
Experimental
Arm Description
Patients will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Arm Title
Group Duloxetine
Arm Type
Experimental
Arm Description
Patients will receive oral duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
Arm Title
Group Pregabalin& Duloxetine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
12 weeks
Title
Total dose of intraoperative fentanyl.
Description
The total dose of intraoperative fentanyle administration rather than the dose used in induction
Time Frame
2 hours intraoperative
Title
Heart rate
Description
Heart rate will be measured preoperative as baseline value, intraoperative and postoperative
Time Frame
24 hours
Title
Mean arterial pressure
Description
Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative.
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant Abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Sabry
Email
marysabry136@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bassant abdelhamid
City
Cairo
ZIP/Postal Code
1772
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30020088
Citation
Altiparmak B, Guzel C, Gumus Demirbilek S. Comparison of Preoperative Administration of Pregabalin and Duloxetine on Cognitive Functions and Pain Management After Spinal Surgery: A Randomized, Double-blind, Placebo-controlled Study. Clin J Pain. 2018 Dec;34(12):1114-1120. doi: 10.1097/AJP.0000000000000640.
Results Reference
background
PubMed Identifier
26982602
Citation
Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, DuMerton-Shore D, Walker S. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016 Jul;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.
Results Reference
background

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Duloxetine vs Pregabalin for Thoracotomy Pain

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