HyperalgesiaPhase 4NCT02934763
Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol
A Phase 4 study testing Propranolol and Saline in people with Hyperalgesia, run by Pontificia Universidad Catolica de Chile.
Trial summary
Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy volunteers and in animal models. Is defined as an increase in the perception to painful stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- Propranolol and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to May 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiology Score (ASA) I-II
Who cannot join
- Medical history of cardiac disease
- Medical history of respiratory disease
- Regular use of beta blockers
- Known allergies to drugs used in the study
- Known history of illicit drugs use
About this study
Official title: Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol, in Laparoscopic Abdominal Surgery
Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy volunteers and in animal models. Is defined as an increase in the perception to painful stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli.
The apparition of OIH is also related to the exposure to opioids during surgery, depending of the dose, the time of exposition and the type of opioid.
Read more
This condition can be modulated, specially in the perioperative context. It has been seen in healthy volunteers and in animal models, than the use of propranolol can modulate this phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the dose of propranolol required to modulate adequately OIH.
The objective of this work is to evaluate the efficacy of propranolol in the modulation of opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.
Read the detailed description
This is a randomized controlled study, comparing 2 interventions with a placebo. The interventions will be use of propranolol, at different doses, to achieve specific plasmatic concentrations.
80 patients will be required to find a difference of 20% in the primary outcome.
The primary outcome to be measured is the postoperative use of opioids in the post anesthesic care unit.
Secondary outcomes, will be the amount of opioids used in the following 24 hours to the surgery, the time to the first dose of analgesia in the post anesthesic care unit, and the change in the pain thresholds, evaluated as pain by pressure and by tactile sensitivity, before and after surgery.
Also, as a secondary outcome, in a group than will not receive the study drug, we will evaluate the temporal changes in opioid induced hyperalgesia, by pain sensitivity measured in the postoperative hours 2, 4 and 24. 10 patients receiving placebo will be part of this additional measures.
- Conditions
- Hyperalgesia
- Being tested
- Propranolol, Saline
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Beta blocker
propranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals
SalineDrug
Also called Placebo
Saline as placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline solution by target controlled infusion Receives: Drug: Saline |
| Propranolol at 5ng/ml target dose | Active comparator | Propranolol iv by target controlled infusion, to achieve a plasmatic concentration of 5ng/ml Receives: Drug: Propranolol |
| Propranolol at 15ng/ml target dose | Active comparator | Propranolol iv by target controlled infusion, to achieve a plasmatic concentration of 15ng/ml Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid use
Dose of opioid required to manage pain adequately
Measured: 24 hours posterior to surgery
Secondary outcomes (4)
Pain thresholds (heat)
Evaluation of the threshold to perceive a heat perception as pain
Measured: 24 hours posterior to surgery
Pain thresholds (cold)
Evaluation of the threshold to perceive a cold perception as pain
Measured: 24 hours posterior to surgery
Pain thresholds (tactile sensitivity)
Evaluation of pain by tactile sensitivity, using the PinPrick system
Measured: 24 hours posterior to surgery
Temporal changes in pain sensibility
Evaluation of pain by tactile sensitivity, using the PinPrick system
Measured: 24 hours posterior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934763
- Sponsor's protocol ID
- 16-145
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol, in Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02934763
- Acronym / sponsor ID
- 16-145
- Conditions
- Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Oct 2016 (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.
Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy volunteers and in animal models. Is defined as an increase in the perception to painful stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli.
The apparition of OIH is also related to the exposure to opioids during surgery, depending of the dose, the time of exposition and the type of opioid.
This condition can be modulated, specially in the perioperative context. It has been seen in healthy volunteers and in animal models, than the use of propranolol can modulate this phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the dose of propranolol required to modulate adequately OIH.
The objective of this work is to evaluate the efficacy of propranolol in the modulation of opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.
Detailed description
This is a randomized controlled study, comparing 2 interventions with a placebo. The interventions will be use of propranolol, at different doses, to achieve specific plasmatic concentrations.
80 patients will be required to find a difference of 20% in the primary outcome.
The primary outcome to be measured is the postoperative use of opioids in the post anesthesic care unit.
Secondary outcomes, will be the amount of opioids used in the following 24 hours to the surgery, the time to the first dose of analgesia in the post anesthesic care unit, and the change in the pain thresholds, evaluated as pain by pressure and by tactile sensitivity, before and after surgery.
Also, as a secondary outcome, in a group than will not receive the study drug, we will evaluate the temporal changes in opioid induced hyperalgesia, by pain sensitivity measured in the postoperative hours 2, 4 and 24. 10 patients receiving placebo will be part of this additional measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline solution by target controlled infusion |
| Propranolol at 5ng/ml target dose | Active comparator | Drug: PropranololPropranolol iv by target controlled infusion, to achieve a plasmatic concentration of 5ng/ml |
| Propranolol at 15ng/ml target dose | Active comparator | Drug: PropranololPropranolol iv by target controlled infusion, to achieve a plasmatic concentration of 15ng/ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiology Score (ASA) I-II
Key exclusion criteria (5 listed)
- Medical history of cardiac disease
- Medical history of respiratory disease
- Regular use of beta blockers
- Known allergies to drugs used in the study
- Known history of illicit drugs use
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 |
|---|---|---|
| PropranololAlso: Beta blockerpropranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals | Drug | Propranolol at 15ng/ml target dose, Propranolol at 5ng/ml target dose |
| SalineAlso: PlaceboSaline as placebo | Drug | Placebo |
Primary outcome
Postoperative opioid use
Time frame: 24 hours posterior to surgery
Dose of opioid required to manage pain adequately
4 secondary outcomes
Pain thresholds (heat)
Time frame: 24 hours posterior to surgery
Pain thresholds (cold)
Time frame: 24 hours posterior to surgery
Pain thresholds (tactile sensitivity)
Time frame: 24 hours posterior to surgery
Temporal changes in pain sensibility
Time frame: 24 hours posterior to surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol and Saline in people with Hyperalgesia, run by Pontificia Universidad Catolica de Chile.
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 2 inclusion and 5 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 27 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid use (time frame: 24 hours posterior to surgery). 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 27 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.