the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

Study Overview
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Brief Summary
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The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study

Detailed Description
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Aim of the work: 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.

Official Title
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The Effect of Pregabalin on Post-operative Pain and Opioid Consumption in Spine Surgery, a Prospective, Randomized, Controlled Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Pregabalin 150mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery | Drug: Pregabalin 150mg<br>* The effect of pregabalin on post-operative pain<br>* Other names: Pregabalin;|
| Placebo Comparator: Placebo group<br>patients will receive placebo 1 hour before surgery with a sip of water. | Other: Placebo<br>* patients will receive placebo one hour before operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphia dose | the total amount of rescue morphine received by patients for 24h postoperatively. | 24 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | post operative VAS score | 24 hour postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin