Postoperative Pain ControlNCT01614236
Pre- Versus Post-Incisional Pregabalin for Postoperative Pain Control
A study testing pregabalin and epidural in people with Postoperative Pain Control and Multimodal Analgesia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain Control, Multimodal Analgesia
- What is being tested?
- pregabalin and epidural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Aug 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 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 the detailed description
Pregablain Interest has been focused on the analgesic, sedative, anxiolytic, and opioid¬sparing effects of pregabalin (PGL) (S+ 3-isobutyl GABA), a structural analog of GABA and a derivative of gabapentin in various pain settingsl including postoperative pain . Of a similar mechanism of action, it is thought to possess a superior phannacokinetic profile than gabapentin [15]. Pregabalin has a variable role in neuropathic pain conditions, such as post-herpetic neuralgia, painful diabetic neuropathy, central neuropathic pain, and fibromyalgia . Some studies had not demonstrated a significant analgesic effect in the acute, postoperative pain; others propose PGL to have effective sedative and opioid-sparing effects, both useful characteristics for the control of acute pain. Opioid sparing effects and improved pain scores have been seen after abdominal and pelvic surgery. Its many potential actions such as reducing opioid reqUirements, prevention and reduction of opioid tolerance, improvement of the quality of opioid analgesia, decreased respiratory depression, relief of anxiety, and gastriC sparing, make it an attractive drug to consider for control of pain in the post operative period.
Population characteristics The orthopedic oncological patients are a specific group of individuals whose demand for antinociception starts rather before surgery because of the bone tumor-generated pain that usually signals the first the existence of pathology. Also, pain intensity that is generated by an intervention on the skeleton is more intense than that induced by damage to soft tissue. Subsequently, these patients would require postoperatively more analgesics than after general surgery and for a longer period of time. We have demonstrated previously that acute pain that is superimposed on an already aroused eNS, i.e., the presence of central sensitization, would create a situation where complete antinociception is hard to obtain, as in these patients, and therefore the efficacy of the antinociceptive protocol is best tested, comprised the possible transformation of acute into chronic pain.
Pre-emption has been pointed out as a beneficial tool for reducing perioperative pain. Various techniques have been employed for this purpose; different drugs were used as well. The beneficial effects of preemptive PGL were documented in patients who had undergone lumbar discectomy, both immediately and 1 and 3 months after surgery.
Hypothesis No studies considered the comparison of preemptive vs. post-surgery PGL only administration, We 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.
Objectives To assess the beneficial effects Of PGL admi"istered either pre-incisionally or post-incisionally on the immediate and late (1-and 3 months) postoperative analgeSia requirements and pain scores, as well as satisfaction rate in the orthopedic oncologic patients.
- Conditions
- Postoperative Pain Control, Multimodal Analgesia
- Being tested
- pregabalin, epidural
- Keywords
- pregabalin, analgesia, postoperative pain, orthopedic oncology patients
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
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
epiduralDrug
patients will be randomized similarly but will undergo surgery under epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | patients will be randomized similarly but will undergo surgery under epidural analgesia Receives: 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 Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain score
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ControlStudies 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
- NCT01614236
- Sponsor's protocol ID
- TASMC-08-WAA-024811-TLV
- Status last verified
- Jun 2012
- First submitted
- 3 Jun 2012
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- Versus Post-Incisional Pregabalin for Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT01614236
- Acronym / sponsor ID
- TASMC-08-WAA-024811-TLV
- Conditions
- Postoperative Pain Control, Multimodal Analgesia
- Keywords
- pregabalin, analgesia, postoperative pain, orthopedic oncology patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 7 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.
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 .
Detailed description
Pregablain Interest has been focused on the analgesic, sedative, anxiolytic, and opioid¬sparing effects of pregabalin (PGL) (S+ 3-isobutyl GABA), a structural analog of GABA and a derivative of gabapentin in various pain settingsl including postoperative pain . Of a similar mechanism of action, it is thought to possess a superior phannacokinetic profile than gabapentin [15]. Pregabalin has a variable role in neuropathic pain conditions, such as post-herpetic neuralgia, painful diabetic neuropathy, central neuropathic pain, and fibromyalgia . Some studies had not demonstrated a significant analgesic effect in the acute, postoperative pain; others propose PGL to have effective sedative and opioid-sparing effects, both useful characteristics for the control of acute pain. Opioid sparing effects and improved pain scores have been seen after abdominal and pelvic surgery. Its many potential actions such as reducing opioid reqUirements, prevention and reduction of opioid tolerance, improvement of the quality of opioid analgesia, decreased respiratory depression, relief of anxiety, and gastriC sparing, make it an attractive drug to consider for control of pain in the post operative period.
Population characteristics The orthopedic oncological patients are a specific group of individuals whose demand for antinociception starts rather before surgery because of the bone tumor-generated pain that usually signals the first the existence of pathology. Also, pain intensity that is generated by an intervention on the skeleton is more intense than that induced by damage to soft tissue. Subsequently, these patients would require postoperatively more analgesics than after general surgery and for a longer period of time. We have demonstrated previously that acute pain that is superimposed on an already aroused eNS, i.e., the presence of central sensitization, would create a situation where complete antinociception is hard to obtain, as in these patients, and therefore the efficacy of the antinociceptive protocol is best tested, comprised the possible transformation of acute into chronic pain.
Pre-emption has been pointed out as a beneficial tool for reducing perioperative pain. Various techniques have been employed for this purpose; different drugs were used as well. The beneficial effects of preemptive PGL were documented in patients who had undergone lumbar discectomy, both immediately and 1 and 3 months after surgery.
Hypothesis No studies considered the comparison of preemptive vs. post-surgery PGL only administration, We 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.
Objectives To assess the beneficial effects Of PGL admi"istered either pre-incisionally or post-incisionally on the immediate and late (1-and 3 months) postoperative analgeSia requirements and pain scores, as well as satisfaction rate in the orthopedic oncologic 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 |
|---|---|---|
| control | Active comparator | Drug: epiduralpatients will be randomized similarly but will undergo surgery under epidural analgesia |
| Lyrica | Active comparator | Drug: pregabalinPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| pregabalinPatients 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 | Drug | Lyrica |
| epiduralpatients will be randomized similarly but will undergo surgery under epidural analgesia | Drug | control |
Primary outcome
post-operative pain score
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pregabalin and epidural in people with Postoperative Pain Control and Multimodal Analgesia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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, draviw@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain score (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2012; AzTrials last refreshed its copy on 31 Oct 2026.