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Duloxetine vs Pregabalin for Thoracotomy Pain

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04782310
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
6.2
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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 :
Mar 10, 2021
Anticipated Primary Completion Date :
Aug 10, 2021
Anticipated Study Completion Date :
Sep 15, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. 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.

  2. Total dose of intraoperative fentanyl. [2 hours intraoperative]

    The total dose of intraoperative fentanyle administration rather than the dose used in induction

  3. Heart rate [24 hours]

    Heart rate will be measured preoperative as baseline value, intraoperative and postoperative

  4. Mean arterial pressure [24 hours postoperative]

    Mean arterial blood pressure will be measured preoperative as baseline value, intraoperative and postoperative.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Bassant abdelhamid Cairo Egypt 1772

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Bassant abdelhamid, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bassant M. Abdelhamid, Associate professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04782310
Other Study ID Numbers:
  • MS-386-2020
First Posted:
Mar 4, 2021
Last Update Posted:
Jun 2, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Pain, Postoperative
Pregabalin
Duloxetine Hydrochloride

Study Results

No Results Posted as of Jun 2, 2021