To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements Clinical Trial
Official title:
Peri-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Elective Neurosurgical Patients: A Randomized, Comparative, Placebo-controlled, Double Blind Study
Background:
Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most
common questions asked by patients pertains to the amount of pain they will experience after
surgery how long it will last and how good will it be controlled. Pain concerns the surgical
team as well, because of its correlation with clinical outcomes and patients' satisfaction
rate. Studies have shown that negative clinical outcome with regard to pain control includes
decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension,
myocardial ischemia, transition into chronic pain, poor wound healing, and psychological
sequelae .
Pain has been found to be one of the three most common medical causes of delayed/aborted
discharge after ambulatory surgery, the other two being drowsiness and postoperative
nausea/vomiting. Despite progress that has been made with regard to postoperative pain
control, and the development of new standards for pain control, many patients continue to
experience intense pain after surgery .
Recent advances in the understanding of the particularities of central sensitization
indicate that it plays an important role in post surgical and post traumatic pain and
therefore should be avoided
Hypothesis:
No studies considered the comparison of pre-emptive and post-incisional or post-surgery PGL
administration. The investigators hypothesize that the administration of PGL preemptively
would diminish pain sensation, and therefore the need for pain administration in
neurosurgical patients, better than postoperatively. In addition, preoperative
administration could reduce the level of anxiety in these patients.
It should be stressed that this study will used a placebo controlled group and at
availuating placebo related psychological effective treatment versus a central efficacy of
Lyrica
Objectives:
To assess the beneficial preemptive and preventive effects of PGL on the immediate and late
(1- and 3 months) postoperative analgesia requirements and pain scores in neurosurgical
patients.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment