AmantadineNCT06833203
Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome
A study testing Amantadine+ Pregabalin and Pregabalin in people with Amantadine and Pregabalin, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amantadine, Pregabalin, Post-thoracotomy Pain Syndrome
- What is being tested?
- Amantadine+ Pregabalin and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18-65) years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical status II, III.
- Body mass index (BMI): (20-40) kg/m2.
- Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures.
Who cannot join
- Patients with known sensitivity or contraindication to drug used in the study.
- History of psychological disorders and/or chronic pain and drug abuse patients.
- Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- Patient refusal.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome; Randomized Controlled Study
This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.
Read the detailed description
Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the primary therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing, as well as the development of post-thoracotomy pain syndrome (PTPS).
Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.
Amantadine (1-aminoadamantane) is NMDA receptor antagonists. NMDA receptors were found to have role in the development of central sensitization, acute opioid tolerance, and opioid induced hyperalgesia.
- Conditions
- Amantadine, Pregabalin, Post-thoracotomy Pain Syndrome
- Being tested
- Amantadine+ Pregabalin, Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine+ PregabalinDrug
Two hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative.
PregabalinDrug
Two hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative.
| Study group | Role | What they receive |
|---|---|---|
| Amantadine group | Experimental | Two hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative. Receives: Drug: Amantadine+ Pregabalin |
| Placebo group | Placebo comparator | Two hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of occurrence of post-thoracotomy pain syndrome
Incidence of occurrence of post-thoracotomy pain syndrome at 12 weeks through according to grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.
Measured: 12 weeks postoperatively
Secondary outcomes (7)
Patient's Quality of life
Patient's Quality of life according to Flanagan Quality of Life Scale (QOLS) which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. Participants respond to the questions using a seven-point Likert scale, ranging from 1 ("completely dissatisfied") to 7 ("delighted"). The scale will be explained to the patients and the total score will be calculated and recorded at the preoperative assessment (baseline) and at postoperative weeks 2, 4, 8, and 12.
Measured: 12 weeks postoperatively
Patient's activity level
Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL).
This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs and transfer) with each item scored as 0 = need complete help, 1 = need some help or 2 = need no help
Measured: 12 weeks postoperatively
Total amount of morphine consumption
Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates Visual Analogue Scale (VAS) ≥ 4.
Measured: 48 hours postoperatively
Total amount of fentanyl consumption
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Measured: Intraoperatively
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. 0 (very much worse" to 7 (very much improved).
Measured: 12 weeks postoperatively
Incidence of side effects of Pregabalin
Side effects of Pregabalin such as headaches, feeling sleepy, tired or dizzy, diarrhoea, mood changes, feeling sick, swollen hands, arms, legs and feet, blurred vision, difficulties with getting an erection, and weight gain - because pregabalin can cause you feel hungry, and memory problems will be recorded.
Measured: 12 weeks postoperatively
Incidence of side effects of Pregabalin
The side effects of Amantadine such as dry mouth, constipation, nausea, vomiting, decreased appetite, difficulty falling asleep or staying asleep, abnormal dreams, headache, confusion, drowsiness, tiredness, uncontrollable tightening of muscles, change from normal walking to falls, and a lace-like purple pattern on the skin.
Measured: 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Dec 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmantadineStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Bekhet Moawad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833203
- Sponsor's protocol ID
- AP2310-201-002
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06833203
- Acronym / sponsor ID
- AP2310-201-002
- Conditions
- Amantadine, Pregabalin, Post-thoracotomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 18 Feb 2025 (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.
This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.
Detailed description
Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the primary therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing, as well as the development of post-thoracotomy pain syndrome (PTPS).
Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.
Amantadine (1-aminoadamantane) is NMDA receptor antagonists. NMDA receptors were found to have role in the development of central sensitization, acute opioid tolerance, and opioid induced hyperalgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amantadine group | Experimental | Drug: Amantadine+ PregabalinTwo hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative. |
| Placebo group | Placebo comparator | Drug: PregabalinTwo hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age (18-65) years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical status II, III.
- Body mass index (BMI): (20-40) kg/m2.
- Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures.
Key exclusion criteria (6 listed)
- Patients with known sensitivity or contraindication to drug used in the study.
- History of psychological disorders and/or chronic pain and drug abuse patients.
- Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
- Patient refusal.
- Severe respiratory or cardiac disorders.
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 |
|---|---|---|
| Amantadine+ PregabalinTwo hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative. | Drug | Amantadine group |
| PregabalinTwo hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative. | Drug | Placebo group |
Primary outcome
Incidence of occurrence of post-thoracotomy pain syndrome
Time frame: 12 weeks postoperatively
Incidence of occurrence of post-thoracotomy pain syndrome at 12 weeks through according to grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.
7 secondary outcomes
Patient's Quality of life
Time frame: 12 weeks postoperatively
Patient's activity level
Time frame: 12 weeks postoperatively
Total amount of morphine consumption
Time frame: 48 hours postoperatively
Total amount of fentanyl consumption
Time frame: Intraoperatively
Patient Global Impression of Change (PGIC)
Time frame: 12 weeks postoperatively
Incidence of side effects of Pregabalin
Time frame: 12 weeks postoperatively
Incidence of side effects of Pregabalin
Time frame: 12 weeks postoperatively
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amantadine+ Pregabalin and Pregabalin in people with Amantadine and Pregabalin, run by Cairo University 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 6 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 6 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Incidence of occurrence of post-thoracotomy pain syndrome (time frame: 12 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.