Back to resultsPregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery
Primary Purpose
Post-Operative Pain
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Celecoxib capsules
Pregabalin 150mg
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Pain
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.
Sites / Locations
- South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group (G)
Group (C)
Arm Description
received gabapentin 300 mg capsule 2 hours preoperative and the same dose 6 hours postoperative.
received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
Outcomes
Primary Outcome Measures
pain control
Visual Analogue Scale for pain measurement.
Secondary Outcome Measures
Full Information
NCT ID
NCT04342065
First Posted
April 7, 2020
Last Updated
April 10, 2020
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04342065
Brief Title
Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group (G)
Arm Type
Active Comparator
Arm Description
received gabapentin 300 mg capsule 2 hours preoperative and the same dose 6 hours postoperative.
Arm Title
Group (C)
Arm Type
Active Comparator
Arm Description
received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
Intervention Type
Drug
Intervention Name(s)
Celecoxib capsules
Intervention Description
received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.
Primary Outcome Measure Information:
Title
pain control
Description
Visual Analogue Scale for pain measurement.
Time Frame
Change from Baseline Visual Analogue Scale every 4 hours for 48 hours (0=no pain 10=most sever pain)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
ZIP/Postal Code
0020
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery
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