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

Cairo University (CU)

Status: Completed

Conditions: Amantadine; Post-thoracotomy Pain Syndrome; Pregabalin

Treatments: Drug: Pregabalin; Drug: Amantadine+ Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT06833203

AP2310-201-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Amantadine group

Experimental group

Description:

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.

Treatment:

Drug: Amantadine+ Pregabalin

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Pregabalin