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

NCT04342065 | Completed Phase 2 DMC

• 1 other identifier: Assuit University
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Group (G)

ACTIVE COMPARATOR

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

Drug: Pregabalin 150mg

Group (C)

ACTIVE COMPARATOR

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

Drug: Celecoxib capsules

Interventions

Celecoxib capsules DRUG

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

Group (C)

Pregabalin 150mg DRUG

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

Group (G)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

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

Asyut, 0020, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib; Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and Pain Relief

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: January 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: February 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)