Pre- Versus Post-Incisional Pregabalin for Postoperative Pain Control
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ClinicalTrials.gov Identifier: NCT01614236 |
Recruitment Status : Unknown
Verified June 2012 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 7, 2012
Last Update Posted : June 7, 2012
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Condition or disease | Intervention/treatment | Phase |
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Postoperative Pain Control Multimodal Analgesia | Drug: pregabalin Drug: epidural | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | August 2013 |

Arm | Intervention/treatment |
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Active Comparator: control
patients will be randomized similarly but will undergo surgery under epidural analgesia
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Drug: epidural
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
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Drug: pregabalin
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 |
- post-operative pain score [ Time Frame: 4 days ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614236
Contact: Avi A Weinbroum, MD | 3-6973237 ext 972 | draviw@tasmc.health.gov.il |
Israel | |
Tel Aviv Sourasky Medical Center | |
Tel Aviv, Israel |
Responsible Party: | Michal Roll PhD,MBA, Resarch and developement Director, Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT01614236 |
Other Study ID Numbers: |
TASMC-08-WAA-024811-TLV |
First Posted: | June 7, 2012 Key Record Dates |
Last Update Posted: | June 7, 2012 |
Last Verified: | June 2012 |
pregabalin analgesia postoperative pain orthopedic oncology patients |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |