Pregabalin for Post-craniotomy Pain Control
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Purpose
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
| Condition | Intervention |
|---|---|
|
To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements |
Drug: Pregabalin Other: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Peri-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Elective Neurosurgical Patients: A Randomized, Comparative, Placebo-controlled, Double Blind Study |
- Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain) [ Time Frame: 8 h ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lyrica
Patients in one group will receive 150 mg of PGL at 20:00 h the night before surgery and at 1.5 h before surgery, and will undergo surgery under general anesthesia (GA).
|
Drug: Pregabalin
Patients in one group will receive 150 mg of PGL at 20:00 h the night before surgery and at 1.5 h before surgery, and will undergo surgery under general anesthesia (GA).
Other Name: Lyrica
|
|
Active Comparator: Control
no liryca treatment
|
Other: Control
pain treatment as customary in the department
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA (American Society of Anesthesiologists) physical status I-III
- patients who will undergo intracranial surgery under general anesthesia only
- Patients undergoing awake-technique procedures will also be enrolled.
Exclusion Criteria:
- allergy to opioids, midazolam, PGL, or non-steroidal anti-inflammatory drugs (NSAIDs), dipyrone
- history of chronic pain or psychiatric disorders and the use of centrally acting antidepressant and antipsychotic drugs. Patients longtime users of sedatives, or antiepileptics
- soldiers and pregnant women
- Emergency cases, DBS procedures and patients unable to comprehend and sign the consent form
Contacts and Locations| Contact: Avi A Weinbroum, MD | 3-6973237 ext 972 | aviw@tasmc.health.gov.il |
More Information
No publications provided
| Responsible Party: | Michal Roll PhD,MBA, Director of the research and development, Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01612832 History of Changes |
| Other Study ID Numbers: | TASMC-08-WAA-016512-TLV |
| Study First Received: | June 4, 2012 |
| Last Updated: | June 5, 2012 |
| Health Authority: | Israel: Ethics Commission |
Additional relevant MeSH terms:
|
Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013