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

Purpose

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	Intervention
Postoperative Pain	Drug: Pregabalin

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	80
Study Start Date:	June 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

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
Study First Received:	May 18, 2011
Last Updated:	June 9, 2011
Health Authority:	Israel: Ministry of Health

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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Pregabalin

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 22, 2013