the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery
NCT ID: NCT05083793
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2020-04-01
2022-01-01
Brief Summary
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Detailed Description
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The aim of our study is to compare the analgesic effect of pre-emptive oral pregabalin 150mg on acute postoperative pain and opioid consumption in spine surgery. Evaluated by visual analog scale (VAS)
primary outcome measure is the total amount of rescue morphine received by patients for 24h postoperatively.
secondary outcome measures include level of acute postoperative pain by VAS, and duration of hospital stay
Patients and methods :
This study will be carried out after being approved from the Medical Research Ethical Committee, Faculty of Medicine, Assiut University, Assiut, Egypt, and after obtaining a written informed consents from all participating patients.
inclusion criteria: This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery
Exclusion criteria : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Study group
patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery
Pregabalin 150mg
The effect of pregabalin on post-operative pain
Placebo group
patients will receive placebo 1 hour before surgery with a sip of water.
Placebo
patients will receive placebo one hour before operation
Interventions
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Pregabalin 150mg
The effect of pregabalin on post-operative pain
Placebo
patients will receive placebo one hour before operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohamed galal aly
Professor of anesthesia and intensive care
Principal Investigators
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Mahmoud Maher, MD
Role: STUDY_CHAIR
Assiut University Hospitals
Locations
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Mahmoud Maher
Asyut, , Egypt
Countries
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References
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Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.
Hindmarch I, Trick L, Ridout F. A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl). 2005 Dec;183(2):133-43. doi: 10.1007/s00213-005-0172-7. Epub 2005 Nov 9.
Sebastian B, Talikoti AT, Nelamangala K, Krishnamurthy D. Effect of Oral Pregabalin as Preemptive Analgesic in Patients Undergoing Lower Limb Orthopedic Surgeries under Spinal Anaesthesia. J Clin Diagn Res. 2016 Jul;10(7):UC01-4. doi: 10.7860/JCDR/2016/18854.8081. Epub 2016 Jul 1.
Related Links
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Pregabalin pharmacology and its relevance to clinical practice
Other Identifiers
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17101526
Identifier Type: -
Identifier Source: org_study_id