Pregabalin for Post-craniotomy Pain Control

NCT ID: NCT01612832

Last Updated: 2012-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

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

Detailed Description

Hypothesis:

No studies considered the comparison of pre-emptive and post-incisional or post-surgery PGL administration. The investigators hypothesize that the administration of PGL preemptively would diminish pain sensation, and therefore the need for pain administration in neurosurgical patients, better than postoperatively. In addition, preoperative administration could reduce the level of anxiety in these patients.

It should be stressed that this study will used a placebo controlled group and at availuating placebo related psychological effective treatment versus a central efficacy of Lyrica

Objectives:

To assess the beneficial preemptive and preventive effects of PGL on the immediate and late (1- and 3 months) postoperative analgesia requirements and pain scores in neurosurgical patients.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lyrica

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).

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: 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).

Control

no liryca treatment

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

pain treatment as customary in the department

Interventions

Pregabalin

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).

Intervention Type: DRUG

Control

pain treatment as customary in the department

Intervention Type: OTHER

Other Intervention Names

Lyrica

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michal Roll PhD,MBA

Director of the research and development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Avi A Weinbroum, MD

Role: CONTACT

aviw@tasmc.health.gov.il

3-6973237 ext. 972

References

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.

Reference Type: DERIVED

PMID: 26871201 (View on PubMed)

Other Identifiers

TASMC-08-WAA-016512-TLV

Identifier Type: -

Identifier Source: org_study_id