the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery
Study Details
Study Description
Brief Summary
The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study group patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery |
Drug: Pregabalin 150mg
The effect of pregabalin on post-operative pain
Other Names:
|
| Placebo Comparator: Placebo group patients will receive placebo 1 hour before surgery with a sip of water. |
Other: Placebo
patients will receive placebo one hour before operation
|
Outcome Measures
Primary Outcome Measures
- Morphia dose [24 hour postoperative]
the total amount of rescue morphine received by patients for 24h postoperatively.
Secondary Outcome Measures
- Postoperative pain [24 hour postoperative]
post operative VAS score
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mahmoud Maher | Assiut | Egypt | 11174 |
Sponsors and Collaborators
- Assiut University
Investigators
- Study Chair: Mahmoud Maher, MD, Assiut University Hospitals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. Review.
- 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. 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.
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