Clinical trial · Interventional
The Efficacy of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery.
Evaluation of the Efficacy of Perioperative Administration of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery. A Double-Blinded Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-mastectomy Pain Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pregabalin | Drug | — | UNRESOLVED |
| Tianeptine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- pregabalin group (group P)
- description
- 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.
- interventionNames
- Drug: Pregabalin
- type
- ACTIVE_COMPARATOR
- label
- Tianeptine group (group T)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer female patients. 2. ASA class II and III. 3. Age ≥ 18 and ≤ 60 Years. 4. Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2. 5. Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection. Exclusion Criteria: 1. Patient refusal. 2. Age \<18 years or \>65 years. 3. BMI \<20 kg/m2 and \>35 kg/m2. 4. Known sensitivity or contraindication to drugs used in the study (Pregabalin , Tianeptine , NSAIDs, or morphine ). 5. History of psychiatric disorders or history of major depression. 6. History of chronic pain that necessitates morphine at a daily dose of 30 mg or more (or equivalent opioids). 7. history of gapabentenoids or antidepressant intake in the preceding three months. 8. Major medical conditions. 9. Pregnancy or lactation.
References
Publications (6)
- BACKGROUNDSung 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
- BACKGROUNDDhankhar 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
- BACKGROUNDJoshi 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
- BACKGROUNDCapuco 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
- BACKGROUNDSamuels 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
- BACKGROUNDReyad 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