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Pre- Versus Post-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Orthopedic Oncologic Patients

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ClinicalTrials.gov Identifier: NCT01359059
Recruitment Status : Unknown
Verified June 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 24, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

Hypothesis

No studies considered the comparison of preemptive vs. post-surgery Pregabalin (PGL) only administration. The investigators 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.


Condition or disease Intervention/treatment
Postoperative Pain Drug: Pregabalin

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pre- vs. Post-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Orthopedic Oncologic Patients: A Comparative, Randomized, Double Blind Study Protocol
Study Start Date : June 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: IV-PCA (Patient-controlled analgesia) morphine Drug: Pregabalin
Patients in one set (40 patients/set) will receive 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. The 2nd set of patients will be randomized similarly but will undergo surgery under epidural analgesia. One physician whose duty in the study will end at the point of preoperative preparation will provide the patients with the preemptive drug. No other premedication will be administered to any patient. Post-operatively, patients who received preoperative PGL patients will be given placebo while the pre-surgery-placebo-treated ones will receive PGL, all at 2 h after surgery. All patients will then be given 150 mg twice daily thereafter, Q 12 h postoperatively up to 96 h.
Active Comparator: Patient controlled epidural analgesia (PCEA) fentanyl Drug: Pregabalin
Patients in one set (40 patients/set) will receive 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. The 2nd set of patients will be randomized similarly but will undergo surgery under epidural analgesia. One physician whose duty in the study will end at the point of preoperative preparation will provide the patients with the preemptive drug. No other premedication will be administered to any patient. Post-operatively, patients who received preoperative PGL patients will be given placebo while the pre-surgery-placebo-treated ones will receive PGL, all at 2 h after surgery. All patients will then be given 150 mg twice daily thereafter, Q 12 h postoperatively up to 96 h.



Primary Outcome Measures :
  1. To assess the beneficial effects of PGL administered either pre-incisionally or post-incisionally on the immediate and late (1- and 3 months) postoperative analgesia requirements and pain scores [ Time Frame: 2 years ]

    In the PACU (post-anesthesia care unit), the parameters (pain, sedation, feeling of anxiety, total morphine, fentanyl, and bupivacaine consumptions, PCA activation, antinociceptives PO/IV, overall maximal pain intensity throughout the study period) will be assessed by the attending physician every 15 min for the first postoperative hour and every 30 min thereafter.

    On the ward, vital signs will be recorded Q 8 h.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III patients who will undergo bone with or without soft tissue cancer surgery type II and III [24,25] under general or epidural anesthesia in Tel-aviv Sourasky Medical Center will be enrolled to this study that will be approved by our institutional human research and ethics committee.
  • All participants will sign a Helsinki-approved informed consent, and will be given full explanation of the drug, PCA and the numerical rating scale (NRS) during the pre-anesthesia interview.

Exclusion Criteria:

  • These will include allergy to opioids, bupivacaine, midazolam, PGL, or non-steroidal anti-inflammatory drugs (NSAIDs), a history of chronic pain or psychiatric disorders and the use of centrally acting drugs of any sort. Patients <18 or >80 years, soldiers and pregnant women will also be excluded from the study.

Information from the National Library of Medicine

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): NCT01359059


Contacts
Contact: AVI Weinbroum, MD 972-524266459 aviw@tasmc.health.gov.il
Contact: Elia Dery, MSc 972-36974093 eliadery@zahav.net.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, weizman 6, Israel, 64239
Contact: Avi Weinbroum, MD    972-524266459    aviw@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Avi Weinbroum, MD Tel-Aviv Sourasky Medical Center

Responsible Party: Avi A Weinbroum, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01359059     History of Changes
Other Study ID Numbers: TASMC-11-HF-0248-11-CTIL
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Tel-Aviv Sourasky Medical Center:
assess the beneficial effects of PGL administered either pre or post surgery
assess the satisfaction rate in the orthopedic oncologic patients

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics
Pregabalin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs