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

Post-Operative Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342065
• Other study ID #: Assuit University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2020
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain

Intervention

Drug:
• Celecoxib capsules
received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
• Pregabalin 150mg
received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain control	Visual Analogue Scale for pain measurement.	Change from Baseline Visual Analogue Scale every 4 hours for 48 hours (0=no pain 10=most sever pain)