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Completed

NCT Number: NCT06833203

Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome

This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.

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Key information

Conditions

Amantadine Post-thoracotomy Pain Syndrome Pregabalin

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Amantadine+ Pregabalin

Drug

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.

Pregabalin

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient's Quality of life

    Time frame: 12 weeks postoperatively

    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.

  2. Patient's activity level

    Time frame: 12 weeks postoperatively

    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

  3. Total amount of morphine consumption

    Time frame: 48 hours postoperatively

    Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates Visual Analogue Scale (VAS) ≥ 4.

  4. Total amount of fentanyl consumption

    Time frame: Intraoperatively

    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.

  5. Patient Global Impression of Change (PGIC)

    Time frame: 12 weeks postoperatively

    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).

  6. Incidence of side effects of Pregabalin

    Time frame: 12 weeks postoperatively

    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.

  7. Incidence of side effects of Pregabalin

    Time frame: 12 weeks postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome; Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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