Pregabalin for Post-craniotomy Pain Control

NCT01612832 | Unknown

• 1 other identifier: TASMC-08-WAA-016512-TLV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: 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 . Pain has been found to be one of the three most common medical causes of delayed/aborted discharge after ambulatory surgery, the other two being drowsiness and postoperative nausea/vomiting. Despite progress that has been made with regard to postoperative pain control, and the development of new standards for pain control, many patients continue to experience intense pain after surgery . Recent advances in the understanding of the particularities of central sensitization indicate that it plays an important role in post surgical and post traumatic pain and therefore should be avoided

Conditions

To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements

Outcome Measures

Primary Outcomes (1)

• Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain)

  8 h

Study Arms (2)

Lyrica

EXPERIMENTAL

Patients in one group will receive 150 mg of PGL at 20:00 h the night before surgery and at 1.5 h before surgery, and will undergo surgery under general anesthesia (GA).

Drug: Pregabalin

Control

ACTIVE COMPARATOR

no liryca treatment

Other: Control

Interventions

Pregabalin DRUG

Patients in one group will receive 150 mg of PGL at 20:00 h the night before surgery and at 1.5 h before surgery, and will undergo surgery under general anesthesia (GA).

Also known as: Lyrica

Lyrica

Control OTHER

pain treatment as customary in the department

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 (American Society of Anesthesiologists) physical status I-III
• patients who will undergo intracranial surgery under general anesthesia only
• Patients undergoing awake-technique procedures will also be enrolled.

You may not qualify if:

• allergy to opioids, midazolam, PGL, or non-steroidal anti-inflammatory drugs (NSAIDs), dipyrone
• history of chronic pain or psychiatric disorders and the use of centrally acting antidepressant and antipsychotic drugs. Patients longtime users of sedatives, or antiepileptics
• soldiers and pregnant women
• Emergency cases, DBS procedures and patients unable to comprehend and sign the consent form

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (1)

• Shimony N, Amit U, Minz B, Grossman R, Dany MA, Gonen L, Kandov K, Ram Z, Weinbroum AA. Perioperative pregabalin for reducing pain, analgesic consumption, and anxiety and enhancing sleep quality in elective neurosurgical patients: a prospective, randomized, double-blind, and controlled clinical study. J Neurosurg. 2016 Dec;125(6):1513-1522. doi: 10.3171/2015.10.JNS151516. Epub 2016 Feb 12.

  PMID: 26871201 DERIVED

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Avi A Weinbroum, MD

CONTACT

3-6973237; aviw@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: Director of the research and development

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Last Updated: June 6, 2012

Record last verified: 2012-06