Duloxetine vs Pregabalin for Thoracotomy Pain

NCT04782310 | Unknown Phase 4 DMC

• 1 other identifier: MS-386-2020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours postoperative

Secondary Outcomes (4)

• Visual analogue scale

  12 weeks

• Total dose of intraoperative fentanyl.

  2 hours intraoperative

• Heart rate

  24 hours

• Mean arterial pressure

  24 hours postoperative

Study Arms (3)

Group Pregabalin

EXPERIMENTAL

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

Drug: Pregabalin

Group Duloxetine

EXPERIMENTAL

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

Drug: Duloxetine

Group Pregabalin& Duloxetine

EXPERIMENTAL

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; Drug: Duloxetine

Interventions

Pregabalin DRUG

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

Group Pregabalin; Group Pregabalin& Duloxetine

Duloxetine DRUG

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

Group Duloxetine; Group Pregabalin& Duloxetine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ● 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.

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Bassant abdelhamid

Cairo, 1772, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 30020088 BACKGROUND

• 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.

  PMID: 26982602 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bassant abdelhamid

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bassant Abdelhamid

CONTACT

01224254012; bassantmohamed197@yahoo.com

Mary Sabry

CONTACT

marysabry136@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: March 10, 2021
• Primary Completion: August 10, 2021
• Study Completion: September 15, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)