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Completed

NCT Number: NCT04342065

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

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Asyut, 0020, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Celecoxib capsules

Drug

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

Pregabalin 150mg

Drug

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

Primary outcomes

  1. pain control

    Time frame: Change from Baseline Visual Analogue Scale every 4 hours for 48 hours (0=no pain 10=most sever pain)

    Visual Analogue Scale for pain measurement.

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Registry information

Official study title

Efficacy of Pre-emptive Different Doses of Oral Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Patients Subjected for Elective Lumbar Spine Fixation Surgery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2020
Registry last updated
Apr 14, 2020

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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