Post-mastectomy Pain SyndromeNCT05935059
The Efficacy of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery.
A study testing Pregabalin and Tianeptine in people with Post-mastectomy Pain Syndrome, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- Pregabalin and Tianeptine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jun 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- history of gapabentenoids or antidepressant intake in the preceding three months.
- Major medical conditions.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.
Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
The International Association for the Study of Pain (IASP) defines PMPS as pain which persists more than 3 months after mastectomy that affects the anterior thorax, axilla, and/or medial upper arm. It is usually described as the feeling of burning, stabbing, and pulling around the treatment side. The underlying pathophysiology of PMPS is highly complicated and involves both peripheral and central sensitization. It results from injury to the peripheral nerves in the axilla or the chest wall during the dissection of axillary lymph nodes. Multiple risk factors are involved in the development of PMPS including acute postoperative pain, age < 40 years, increased BMI , diagnosis at later-stage disease, psychosocial factors (i.e., anxiety, depression, sleep disturbances, catastrophizing), preoperative pain and adjuvant therapy (chemotherapy, radiation therapy).(8)Because PMP involves issues associated not only with pain management, but also with psychosocial disruption, the assessment of each of these domains should be addressed routinely so as to enable early detection and treatment.
Different pharmacological tools have been in use for either prevention or treatment of such refractory pain syndrome with variable efficacy.
Tianeptine is a unique antidepressant and anxiolytic medication that stimulates the uptake of serotonin (5-hydroxytryptamine; 5-HT), and 5-hydroxyindoleacetic acid (5-HIAA) in brain tissue . It acts as a full agonist at the mu-type opioid receptor (MOR) , the serotonin receptor ,dopamine (D2/3) receptors and glutamate receptors .It also reduces the hypothalamic-pituitary-adrenal response to stress, and thus prevents stress-related behavioral issues.
Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter γ-aminobutyric acid. It is an α2-δ (α2-δ) ligand that has analgesic, anticonvulsant, anxiolytic, and sleep-modulating activities. Pregabalin binds potently to the α2-δ subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters, including glutamate, noradrenaline, serotonin, dopamine, and substance P , Pregabalin has also been found to be effective at reducing acute postoperative pain The efficacy of pregabalin in treating acute postsurgical pain has been demonstrated in numerous studies. A recent meta-analysis has suggested that pregabalin, at all doses and administration regimens, has opioid-sparing effects and reduces pain scores in the postsurgical setting, at the expense of increased sedation and visual disturbances; however, the efficacy of pregabalin in providing such in various surgical categories remains uncertain, and it is not known whether the risk: benefit ratio is greater for certain surgical categories 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
- Being tested
- Pregabalin, Tianeptine
- Keywords
- Breast cancer, Post mastectomy pain, chronic pain
- Medical subject headings
- Breast Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Anticonvulsant
Pregabalin 50Mg Oral Capsule. Pre-operative administration of Pregabalin for prevention of Post mastectomy Pain Syndrome (PMPS)
TianeptineDrug
Also called Antidepressant
Tianeptine 12.5Mg Capsules. Prevention of Post Mastectomy Pain Syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tianeptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients who developed Post Mastectomy Pain Syndrome (PMPS)
The Percentage of patients developing Post Mastectomy Pain Syndrome (PMPS)
Measured: 6 months
Secondary outcomes (8)
Changes and stability in Mean Arterial Blood Pressure (MAP)
Change in Mean Arterial Blood Pressure (MAP) in mmHg
Measured: 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)
Change in heart rate (HR) in beat\min
Measured: 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
the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups
Measured: Time of surgery
1st time opioids requested post-operative.
In case of postoperative pain recorded, rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient VAS Score ≥ 4. The total amount of morphine given in 24 hours will be recorded for both groups
Measured: 24 hours after the surgery
Total amount of morphine consumed postoperatively
The total 24-hour morphine consumption will be recorded for every patient post operative.
Measured: 24 hours after the surgery
The degree of postoperative sedation according to Ramsay scores.
Sedation will be assessed with Ramsay score (1 = anxious or restless or both; 2 = cooperative, orientated, and tranquil; 3= responding to commands; 4 = brisk response to stimulus; 5 = sluggish response to stimulus; and 6 = no response to stimulus). A Ramsay score of 5 or 6 will be considered excessively high sedation levels; a Ramsay score of 2 to 4 will be considered adequate sedation levels needing observation; a Ramsay score of 1 will be considered inadequate or insufficient sedation Levels
Measured: 24 hours
Postoperative nausea and vomiting (PONV).
Postoperative nausea and vomiting (PONV) will be rated on a four-point verbal scale; (none =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe =vomiting >one attack). 0.1 mg/kg of IV ondansetron will be given to patients with moderate or severe postoperative nausea and vomiting.
Measured: 24 hours
Severity of PMPS according to Grading system for neuropathic pain (GSNP)
Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP). Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) i.e. GSNP ≥ 3 . Grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite )
Measured: 6 motnths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start21 Jun 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Sharawy Abdel Rahman Aboul Nasr, National Cancer Institute, Egypt
- Investigators
- Ayman Sharawy Abdel Rahman Aboul Nasr, MD, Principal investigator, National Cancer Institute Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935059
- Sponsor's protocol ID
- AP2305.501.039
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33538338Dhankhar 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.
PubMed 20677900Joshi 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.
PubMed 15763409Capuco 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.
PubMed 32529416Samuels 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.
PubMed 28303899Reyad 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.
PubMed 30359684
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05935059
- Acronym / sponsor ID
- AP2305.501.039
- Conditions
- Post-mastectomy Pain Syndrome
- Keywords
- Breast cancer, Post mastectomy pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.
Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
The International Association for the Study of Pain (IASP) defines PMPS as pain which persists more than 3 months after mastectomy that affects the anterior thorax, axilla, and/or medial upper arm. It is usually described as the feeling of burning, stabbing, and pulling around the treatment side. The underlying pathophysiology of PMPS is highly complicated and involves both peripheral and central sensitization. It results from injury to the peripheral nerves in the axilla or the chest wall during the dissection of axillary lymph nodes. Multiple risk factors are involved in the development of PMPS including acute postoperative pain, age < 40 years, increased BMI , diagnosis at later-stage disease, psychosocial factors (i.e., anxiety, depression, sleep disturbances, catastrophizing), preoperative pain and adjuvant therapy (chemotherapy, radiation therapy).(8)Because PMP involves issues associated not only with pain management, but also with psychosocial disruption, the assessment of each of these domains should be addressed routinely so as to enable early detection and treatment.
Different pharmacological tools have been in use for either prevention or treatment of such refractory pain syndrome with variable efficacy.
Tianeptine is a unique antidepressant and anxiolytic medication that stimulates the uptake of serotonin (5-hydroxytryptamine; 5-HT), and 5-hydroxyindoleacetic acid (5-HIAA) in brain tissue . It acts as a full agonist at the mu-type opioid receptor (MOR) , the serotonin receptor ,dopamine (D2/3) receptors and glutamate receptors .It also reduces the hypothalamic-pituitary-adrenal response to stress, and thus prevents stress-related behavioral issues.
Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter γ-aminobutyric acid. It is an α2-δ (α2-δ) ligand that has analgesic, anticonvulsant, anxiolytic, and sleep-modulating activities. Pregabalin binds potently to the α2-δ subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters, including glutamate, noradrenaline, serotonin, dopamine, and substance P , Pregabalin has also been found to be effective at reducing acute postoperative pain The efficacy of pregabalin in treating acute postsurgical pain has been demonstrated in numerous studies. A recent meta-analysis has suggested that pregabalin, at all doses and administration regimens, has opioid-sparing effects and reduces pain scores in the postsurgical setting, at the expense of increased sedation and visual disturbances; however, the efficacy of pregabalin in providing such in various surgical categories remains uncertain, and it is not known whether the risk: benefit ratio is greater for certain surgical categories 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin group (group P) | Active comparator | Drug: Pregabalinpregabalin 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. |
| Tianeptine group (group T) | Active comparator | Drug: TianeptineTianeptine 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: AnticonvulsantPregabalin 50Mg Oral Capsule. Pre-operative administration of Pregabalin for prevention of Post mastectomy Pain Syndrome (PMPS) | Drug | pregabalin group (group P) |
| TianeptineAlso: AntidepressantTianeptine 12.5Mg Capsules. Prevention of Post Mastectomy Pain Syndrome | Drug | Tianeptine group (group T) |
Primary outcome
the percentage of patients who developed Post Mastectomy Pain Syndrome (PMPS)
Time frame: 6 months
The Percentage of patients developing Post Mastectomy Pain Syndrome (PMPS)
8 secondary outcomes
Changes and stability in Mean Arterial Blood Pressure (MAP)
Time frame: 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)
Time frame: 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 frame: Time of surgery
1st time opioids requested post-operative.
Time frame: 24 hours after the surgery
Total amount of morphine consumed postoperatively
Time frame: 24 hours after the surgery
The degree of postoperative sedation according to Ramsay scores.
Time frame: 24 hours
Postoperative nausea and vomiting (PONV).
Time frame: 24 hours
Severity of PMPS according to Grading system for neuropathic pain (GSNP)
Time frame: 6 motnths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 33538338Sung 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.
- Background: PubMed 20677900Dhankhar 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.
- Background: PubMed 15763409Joshi 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.
- Background: PubMed 32529416Capuco 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.
- Background: PubMed 28303899Samuels 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.
- Background: PubMed 30359684Reyad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Sharawy Abdel Rahman Aboul Nasr, MD principal investigator
National Cancer Institute Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Tianeptine in people with Post-mastectomy Pain Syndrome, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients who developed Post Mastectomy Pain Syndrome (PMPS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935059, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.