Postoperative PainPhase 4OFANCT03124082
OFA - Opioid Free Anesthesia
A Phase 4 study testing Remifentanil, Ketamine and Lidocaine in people with Postoperative Pain, run by University of Parma at 1 site in Italy.
Trial summary
Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH). OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Remifentanil, Ketamine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jan 2017to 31 Mar 2018
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left hemicolectomy
- signed informed consent
- >18 ys
Who cannot join
- >90 ys <18 ys
- no consent
- pregnancy
- psychiatric disease
- cardiac failure, aortic or mitral valve severe stenosis
- kidney or hepatic failure
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- atrio-ventricular type II block
- immunodepression
- emergency surgery
- ICU admittance
- drug or alcohol abuse
- chronic pain
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital
Parma, Parma, 43100
Bugada Dario, MD
About this study
Official title: Study Protocol "OFA: Opioid-Free Anesthesia".
Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH).
OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.
- Conditions
- Postoperative Pain
- Being tested
- Remifentanil, Ketamine, Lidocaine, Clonidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
continuous infusion intraop
KetamineDrug
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
LidocaineDrug
lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
ClonidineDrug
clonidine 4 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| opioid | Active comparator | remifentanil 0,15-0,25 mcg/kg/h Receives: Drug: Remifentanil |
| opioid free | Experimental | ketamine bolus 0,5 mg/kg + infusion 0,25 mg/kg/h lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h clonidine 4 mcg/kg Receives: Drug: Ketamine; Drug: Lidocaine; Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic consumption
morphine mg by PCA (Patient Controlled Analgesia)
Measured: 24 HOURS
Secondary outcomes (4)
side effects
nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation
Measured: 4 days after surgery
Pain Score on the Visual Analog Scale
VAS (Visual Analog Scale)
Measured: 3 months
peripheral sensitization
assessment of primary hyperalgesia by Von Frey Filaments at 24 hours
Measured: 24 hours
central sensitization
assessment of secondary hyperalgesia by pin-prick test at 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start4 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blind trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Allegri, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124082
- Sponsor's protocol ID
- 34477
- Acronym
- OFA
- Status last verified
- Apr 2017
- First submitted
- 22 Jan 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol "OFA: Opioid-Free Anesthesia".
- ClinicalTrials.gov ID
- NCT03124082
- Acronym / sponsor ID
- OFA / 34477
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 21 Apr 2017 (actual)
- 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.
Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH).
OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind trial
| Arm | Type | Receives |
|---|---|---|
| opioid | Active comparator | Drug: Remifentanilremifentanil 0,15-0,25 mcg/kg/h |
| opioid free | Experimental | Drug: Ketamine, Drug: Lidocaine, Drug: Clonidineketamine bolus 0,5 mg/kg + infusion 0,25 mg/kg/h lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h clonidine 4 mcg/kg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- left hemicolectomy
- signed informed consent
- >18 ys
Key exclusion criteria (12 listed)
- >90 ys <18 ys
- no consent
- pregnancy
- psychiatric disease
- cardiac failure, aortic or mitral valve severe stenosis
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 |
|---|---|---|
| Remifentanilcontinuous infusion intraop | Drug | opioid |
| Ketaminebolus 0,5 mg/kg + infusion 0,25 mg/kg/h | Drug | opioid free |
| Lidocainelidocaine bolus 1 mg/kg + infusion 1 mg/kg/h | Drug | opioid free |
| Clonidineclonidine 4 mcg/kg | Drug | opioid free |
Primary outcome
analgesic consumption
Time frame: 24 HOURS
morphine mg by PCA (Patient Controlled Analgesia)
4 secondary outcomes
side effects
Time frame: 4 days after surgery
Pain Score on the Visual Analog Scale
Time frame: 3 months
peripheral sensitization
Time frame: 24 hours
central sensitization
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Remifentanil, Ketamine and Lidocaine in people with Postoperative Pain, run by University of Parma at 1 site in Italy.
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 12 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 21 Apr 2017. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bugada Dario, MD (+390521703567, dariobugada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic consumption (time frame: 24 HOURS). 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 21 Apr 2017.