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
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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 | Phase |
---|---|---|
Postoperative Pain | Drug: Pregabalin | Not Applicable |

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 |

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.
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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.
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- 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 |
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.

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