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

NCT ID: NCT06833203

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-05-01

Brief Summary

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.

Conditions

Amantadine; Pregabalin; Post-thoracotomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Amantadine group

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.

Group Type: EXPERIMENTAL

Amantadine+ Pregabalin

Intervention Type: 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.

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Pregabalin

Intervention Type: 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.

Interventions

Amantadine+ Pregabalin

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.

Intervention Type: DRUG

Pregabalin

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Samuel Bekhet Moawad

Assistant Lecturer of Anesthesia, Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

AP2310-201-002

Identifier Type: -

Identifier Source: org_study_id