To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia RequirementsNCT01612832
Pregabalin for Post-craniotomy Pain Control
A study testing Pregabalin in people with To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peri-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Elective Neurosurgical Patients: A Randomized, Comparative, Placebo-controlled, Double Blind Study
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 .
Read more
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
Read the 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.
- Being tested
- Pregabalin, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called 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).
ControlOther
pain treatment as customary in the department
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Pregabalin |
| Control | Active comparator | no liryca treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain)
Measured: 8 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia RequirementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612832
- Sponsor's protocol ID
- TASMC-08-WAA-016512-TLV
- Status last verified
- Jun 2012
- First submitted
- 4 Jun 2012
- Last updated
- 6 Jun 2012
- Results posted
- No
Publications
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.
PubMed 26871201
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Elective Neurosurgical Patients: A Randomized, Comparative, Placebo-controlled, Double Blind Study
- ClinicalTrials.gov ID
- NCT01612832
- Acronym / sponsor ID
- TASMC-08-WAA-016512-TLV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyrica | Experimental | Drug: PregabalinPatients 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 | Active comparator | Other: Controlno liryca treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaPatients 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 | Lyrica |
| Controlpain treatment as customary in the department | Other | Control |
Primary outcome
Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain)
Time frame: 8 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- Derived from this study: PubMed 26871201Shimony 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with To Assess the Beneficial Preemptive and Preventive Effects of PGL on the Immediate and Late (1- and 3 Months) Postoperative Analgesia Requirements, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avi A Weinbroum, MD (3-6973237 ext. 972, aviw@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain) (time frame: 8 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.