Pre- Versus Post-Incisional Pregabalin for Postoperative Pain Control

NCT01614236 | Unknown

• 1 other identifier: TASMC-08-WAA-024811-TLV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Proper pain relief is a major concern of patients worldwide. Preoperatively, one of the most common questions asked by patients pertains to the amount of pain they will experience after surgery how long it will last and how good will it be controlled. Pain concerns the surgical team as well, because of its correlation with clinical outcomes and patients' satisfaction rate . Studies have shown that negative clinical outcome with regard to pain control includes decreases in vital capacity and alveolar ventilation, pneumonia, tachycardia, hypertension, myocardial ischemia, transition into chronic pain, poor wound healing, and psychological sequelae .

Conditions

Postoperative Pain Control; Multimodal Analgesia

Keywords

pregabalin; analgesia; postoperative pain; orthopedic oncology patients

Outcome Measures

Primary Outcomes (1)

• post-operative pain score

  4 days

Study Arms (2)

control

ACTIVE COMPARATOR

patients will be randomized similarly but will undergo surgery under epidural analgesia

Drug: epidural

Lyrica

ACTIVE COMPARATOR

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

Drug: pregabalin

Interventions

pregabalin DRUG

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

Lyrica

epidural DRUG

patients will be randomized similarly but will undergo surgery under epidural analgesia

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Pregabalin; Injections, Epidural

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Avi A Weinbroum, MD

CONTACT

3-6973237; draviw@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resarch and developement Director

Study Record Dates

• First Submitted: June 3, 2012
• First Posted: June 7, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

IL (1)