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The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery |
|
| Placebo group | Placebo Comparator | patients will receive placebo 1 hour before surgery with a sip of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 150mg | Drug | The effect of pregabalin on post-operative pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphia dose | the total amount of rescue morphine received by patients for 24h postoperatively. | 24 hour postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | post operative VAS score | 24 hour postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Maher, MD | Assiut University Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahmoud Maher | Asyut | 11174 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15315511 | Background | 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. | |
| 16205916 | Background | 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. |
| Label | URL |
|---|---|
| Pregabalin pharmacology and its relevance to clinical practice | View source |
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make individual participant data (IPD) available to other researchers
one year
Study protocol
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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care provider
| Placebo | Other | patients will receive placebo one hour before operation |
|
| 27630927 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |