Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery

NCT ID: NCT04342065

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-02-01

Brief Summary

The anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs (NSAID) such as celecoxib were used as a part of multimodal analgesia to control such pain. Gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia, diabetic neuropathy, and neuropathic pain. Celecoxib is one of the NSAIDs, that its analgesic effect is reported in various studies by cyclooxygenase-2 (COX-2) inhibitor.

The aim of this randomized double-blinded study was to asses and compare the efficacy of using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative hemodynamic control and pain relief in patients underwent posterior approach lumbar spine disc fixation surgery.

Conditions

Post-Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group (G)

received gabapentin 300 mg capsule 2 hours preoperative and the same dose 6 hours postoperative.

Group Type: ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type: DRUG

received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.

Group (C)

received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.

Group Type: ACTIVE_COMPARATOR

Celecoxib capsules

Intervention Type: DRUG

received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.

Interventions

Celecoxib capsules

received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.

Intervention Type: DRUG

Pregabalin 150mg

received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American society of anesthesiologists (ASA) I and II, aged between 21-60 years old scheduled to undergo elective posterior approach lumbar spine disc surgery

Exclusion Criteria

• Patients with a known sensitivity to celecoxib or pregabalin, psychotic disorder or cognitive impairment, history of drug dependency or substance addiction, history of chronic medical disease, the presence of coagulation disorders or pregnancy, were excluded from the study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ali M. Elzohry

Lecturer of Anesthesia, ICU and Pain Relief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Assuit University

Identifier Type: -

Identifier Source: org_study_id