The Efficacy of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery.

NCT05935059 | Completed DMC

• 1 other identifier: AP2305.501.039
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common malignancy among females. Nearly 40% of breast surgery patients experience moderate to severe acute postoperative pain, with severe pain persisting for more than 6 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Different pharmacological tools have been in use for either prevention or treatment of such refractory pain syndrome with variable efficacy. The aim of this study is to assess the efficacy of the perioperative use of Pregabalin versus Tianeptine on the emergence of PMPS in female patients undergoing MRM for breast cancer.

Conditions

Post-mastectomy Pain Syndrome

Keywords

Breast cancer; Post mastectomy pain; chronic pain

Outcome Measures

Primary Outcomes (1)

• the percentage of patients who developed Post Mastectomy Pain Syndrome (PMPS)

  The Percentage of patients developing Post Mastectomy Pain Syndrome (PMPS)

  6 months

Secondary Outcomes (8)

• Changes and stability in Mean Arterial Blood Pressure (MAP)

  every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

• Changes and stability in Heart Rate (HR)

  every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

• Total amount of fentanyl consumed intraoperative

  Time of surgery

• 1st time opioids requested post-operative.

  24 hours after the surgery

• Total amount of morphine consumed postoperatively

  24 hours after the surgery

Study Arms (2)

pregabalin group (group P)

ACTIVE COMPARATOR

pregabalin group (group P) patients will receive pregabalin (Lyrica, Pfizer, NY) 50 mg with a sip of water one hour before induction of anesthesia and repeated every 8 hours for five days after surgery. The pregabalin capsules will be given to patients by nurses blinded to the study. Neither the researcher allocating the participants, nor the assessing person knew the decoding of the groups in its relation to the allocation sequence. Data will be collected by a junior pain resident blinded to the study protocol.

Drug: Pregabalin

Tianeptine group (group T)

ACTIVE COMPARATOR

Tianeptine group (group T) patients will receive Tianeptine 12.5 mg (Stablon, Servier, France)with a sip of water one hour before induction of anesthesia and repeated every 8 hours for five days after surgery. The Tianeptine capsules will be given to patients by nurses blinded to the study. Neither the researcher allocating the participants, nor the assessing person knew the decoding of the groups in its relation to the allocation sequence. Data will be collected by a junior pain resident blinded to the study protocol.

Drug: Tianeptine

Interventions

Pregabalin DRUG

Pregabalin 50Mg Oral Capsule. Pre-operative administration of Pregabalin for prevention of Post mastectomy Pain Syndrome (PMPS)

Also known as: Anticonvulsant

pregabalin group (group P)

Tianeptine DRUG

Tianeptine 12.5Mg Capsules. Prevention of Post Mastectomy Pain Syndrome

Also known as: Antidepressant

Tianeptine group (group T)

Eligibility Criteria

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

You may qualify if:

• Breast cancer female patients.
• ASA class II and III.
• Age ≥ 18 and ≤ 60 Years.
• Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
• Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection.

You may not qualify if:

• Patient refusal.
• Age \<18 years or \>65 years.
• BMI \<20 kg/m2 and \>35 kg/m2.
• Known sensitivity or contraindication to drugs used in the study (Pregabalin , Tianeptine , NSAIDs, or morphine ).
• History of psychiatric disorders or history of major depression.
• History of chronic pain that necessitates morphine at a daily dose of 30 mg or more (or equivalent opioids).
• history of gapabentenoids or antidepressant intake in the preceding three months.
• Major medical conditions.
• Pregnancy or lactation.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute Cairo University

Cairo, 11796, Egypt

Location

Related Publications (6)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Dhankhar R, Vyas SP, Jain AK, Arora S, Rath G, Goyal AK. Advances in novel drug delivery strategies for breast cancer therapy. Artif Cells Blood Substit Immobil Biotechnol. 2010 Oct;38(5):230-49. doi: 10.3109/10731199.2010.494578.

  PMID: 20677900 BACKGROUND

• Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.

  PMID: 15763409 BACKGROUND

• Capuco A, Urits I, Orhurhu V, Chun R, Shukla B, Burke M, Kaye RJ, Garcia AJ, Kaye AD, Viswanath O. A Comprehensive Review of the Diagnosis, Treatment, and Management of Postmastectomy Pain Syndrome. Curr Pain Headache Rep. 2020 Jun 11;24(8):41. doi: 10.1007/s11916-020-00876-6.

  PMID: 32529416 BACKGROUND

• Samuels BA, Nautiyal KM, Kruegel AC, Levinstein MR, Magalong VM, Gassaway MM, Grinnell SG, Han J, Ansonoff MA, Pintar JE, Javitch JA, Sames D, Hen R. The Behavioral Effects of the Antidepressant Tianeptine Require the Mu-Opioid Receptor. Neuropsychopharmacology. 2017 Sep;42(10):2052-2063. doi: 10.1038/npp.2017.60. Epub 2017 Mar 17.

  PMID: 28303899 BACKGROUND

• Reyad RM, Omran AF, Abbas DN, Kamel MA, Shaker EH, Tharwat J, Reyad EM, Hashem T. The Possible Preventive Role of Pregabalin in Postmastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial. J Pain Symptom Manage. 2019 Jan;57(1):1-9. doi: 10.1016/j.jpainsymman.2018.10.496. Epub 2018 Oct 22.

  PMID: 30359684 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Interventions

Pregabalin; Anticonvulsants; tianeptine; Antidepressive Agents

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Psychotropic Drugs

Study Officials

• Ayman Sharawy Abdel Rahman Aboul Nasr, MD

  National Cancer Institute Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: June 21, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

EG (1)