- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01614236
Pre- Versus Post-Incisional Pregabalin for Postoperative Pain Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregablain Interest has been focused on the analgesic, sedative, anxiolytic, and opioid¬sparing effects of pregabalin (PGL) (S+ 3-isobutyl GABA), a structural analog of GABA and a derivative of gabapentin in various pain settingsl including postoperative pain . Of a similar mechanism of action, it is thought to possess a superior phannacokinetic profile than gabapentin [15]. Pregabalin has a variable role in neuropathic pain conditions, such as post-herpetic neuralgia, painful diabetic neuropathy, central neuropathic pain, and fibromyalgia . Some studies had not demonstrated a significant analgesic effect in the acute, postoperative pain; others propose PGL to have effective sedative and opioid-sparing effects, both useful characteristics for the control of acute pain. Opioid sparing effects and improved pain scores have been seen after abdominal and pelvic surgery. Its many potential actions such as reducing opioid reqUirements, prevention and reduction of opioid tolerance, improvement of the quality of opioid analgesia, decreased respiratory depression, relief of anxiety, and gastriC sparing, make it an attractive drug to consider for control of pain in the post operative period.
Population characteristics The orthopedic oncological patients are a specific group of individuals whose demand for antinociception starts rather before surgery because of the bone tumor-generated pain that usually signals the first the existence of pathology. Also, pain intensity that is generated by an intervention on the skeleton is more intense than that induced by damage to soft tissue. Subsequently, these patients would require postoperatively more analgesics than after general surgery and for a longer period of time. We have demonstrated previously that acute pain that is superimposed on an already aroused eNS, i.e., the presence of central sensitization, would create a situation where complete antinociception is hard to obtain, as in these patients, and therefore the efficacy of the antinociceptive protocol is best tested, comprised the possible transformation of acute into chronic pain.
Pre-emption has been pointed out as a beneficial tool for reducing perioperative pain. Various techniques have been employed for this purpose; different drugs were used as well. The beneficial effects of preemptive PGL were documented in patients who had undergone lumbar discectomy, both immediately and 1 and 3 months after surgery.
Hypothesis No studies considered the comparison of preemptive vs. post-surgery PGL only administration, We believe that the administration of PGL preemptively would diminish pain sensation and therefore the need for opioids administration in orthopedic-oncologic patients more effectively than if administered starting postoperatively.
Objectives To assess the beneficial effects Of PGL admi"istered either pre-incisionally or post-incisionally on the immediate and late (1-and 3 months) postoperative analgeSia requirements and pain scores, as well as satisfaction rate in the orthopedic oncologic patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA phYSical status I-III patients who will undergo bone with or without soft tissue cancer surgery type II and III under general or epidural anesthesia
Exclusion Criteria:
- Allergy to opioids, bupivacaine, midazolam, PGL, or non¬steroidal anti-infiammatory dnugs (NSAIDs)
- History of chronic pain or psychiatric disorders
- Use of centrally acting drugs of any sort.
- Soldiers and pregnant women will also be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control
patients will be randomized similarly but will undergo surgery under epidural analgesia
|
patients will be randomized similarly but will undergo surgery under epidural analgesia
|
Active Comparator: Lyrica
Patients will received 150 mg of PGL or placebo at 20:00 the evening before surgery and 1.5 h before surgery and will undergo surgery under GA
|
Patients in one set (40 patients/sct) will received 150 mg of PGL or placebo at 20:00 the evening before surgery and 1.5 h before surgery and will undergo surgery under GA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
post-operative pain score
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- TASMC-08-WAA-024811-TLV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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