HyperalgesiaPhase 4NCT03450161
Hyperalgesia, Persistent Pain, and Fentanyl Dosing in On-Pump Coronary Artery Bypass Grafting
A Phase 4 study testing Fentanyl dosing schemes in people with Hyperalgesia and Opioid Use, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Randomized, double-blinded, three arm study in adult patients undergoing first time coronary artery bypass grafting (CABG) surgery with median sternotomy. The investigators will examine the effects of three fentanyl dosing schemes (high-dose bolus, low-dose bolus, continuous dose) on the area of hyperalgesia and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperalgesia, Opioid Use, Pain, Postoperative
- What is being tested?
- Fentanyl dosing schemes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 14 May 2018to 9 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients aged ≥18 years
- Undergoing first-time, elective, on-pump CABG surgery with median sternotomy and central cannulation.
Who cannot join
- Documentation of preexisting chronic pain as per electronic record
- Use of opioids in the last 30 days or history/documentation of opioid abuse as per electronic record
- BMI > 35kg/m2 or history of obstructive sleep apnea syndrome
- Patients with renal failure (clearance < 30 ml/min)
- Neuraxial anesthesia
- Pregnancy
Show all 9Show fewer
- Planned wound infiltration with local anesthetics
- Known drug allergies or intolerance to fentanyl or other opioids
- Expected to be unable to understand pinprick/allodynia testing / follow-up questions
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, double-blinded, three arm study in adult patients undergoing first time coronary artery bypass grafting (CABG) surgery with median sternotomy. The investigators will examine the effects of three fentanyl dosing schemes (high-dose bolus, low-dose bolus, continuous dose) on the area of hyperalgesia and allodynia at 24 and 48h as well as on persisting pain at 3, 6, and 12 months. Additionally, the investigators will measure fentanyl concentrations throughout anesthesia.
Read the detailed description
A prospective, randomized, double-blinded (patient, anesthesiologist, assessor) clinical study. This study will examine three different clinically used application schemes of fentanyl, an opioid used as the standard of care in routine practice. Patients will be randomized to receive one of the following three treatment arms for anesthesia maintenance (pre-sternotomy):
- High-dose fentanyl bolus (20 µg/kg of body weight [BW]; e.g. 70kg 1400 µg or 1.4mg)
- Low-dose fentanyl bolus (3 µg/kg BW; e.g. 70kg 210 µg or 0.2mg)
- Continuous fentanyl application by Shibutani scheme This study will include data from 69 adult patients (23 per arm) undergoing first time, elective, on-pump CABG surgery with median sternotomy and central cannulation. Following randomization by the sealed envelope technique, fentanyl kits will be drawn up by an anesthesiologist not involved in patient care or outcome assessment. Patients with preexisting chronic pain, opioids in the last 30 days, a BMI>36kg/m2, sleep apnoea, renal failure (clearance <30ml/min), with neuraxial anesthesia, pregnant, with planned wound infiltration, known allergies/intolerance to opioids, and unable to understand pin-prick testing will be excluded. At induction, all patients will receive a standard 3 µg/kg bolus of fentanyl (not study medication, but rather standard of care). 5 minutes prior to sternotomy, the patient will receive analgesia maintenance (one of the three fentanyl study arms). Clinicians will at all times be able to administer a bolus of fentanyl on a perceived "as needed" basis (not study medication, but rather standard of care). The primary objective of this trial is to assess whether or not different intraoperative dosing schemes of fentanyl during on-pump CABG surgery influence the area of hyperalgesia as measured by sternal pin-prick testing on the first postoperative day. As the mechanisms causing opioid-induced analgesia are poorly understood but appear to be dosis-related, the investigators will examine 3 clinically used fentanyl application schemes in cardiac surgery: 1) a high-dose bolus group, 2) a low-dose bolus group, and 3) a low-dose continuous infusion group. [i.e. does fentanyl dosing influence the area of hyperalgesia?] The secondary objectives of this trial are 1) to explore the intraoperative concentrations of fentanyl in these various dosing schemes during and after extracorporeal circulation (ECC). [i.e. determine the time course of fentanyl with ECC and its association with hyperalgesia; explorative] 2) to explore a possible association between fentanyl dosing, hyperalgesia, and persisting pain 3, 6, and 12 months after surgery. [i.e. clinical implication on persistent/chronic pain; explorative]
- Conditions
- Hyperalgesia, Opioid Use, Pain, Postoperative, Pain, Chronic
- Being tested
- Fentanyl dosing schemes
- Medical subject headings
- Hyperalgesia, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl dosing schemesDrug
We routinely use fentanyl as the opioid of choice in CABG surgery. However, how much and whether or not to apply it in boli or continuously remain uncertain. We will apply 3 routinely used fentanyl dosing schemes in our hospital. To blind care-givers and patients, in each of the arms a bolus and a continous injection will occur, as delineated in the treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Bolus of Fentanyl | Experimental | 5 minutes prior to sternotomy, patients will receive a fentanyl bolus of 20 mcg/kg BW (verum) and a perfusion pump with sodium chloride (NaCl 0.9%; placebo) will be begun according to the Shibutani dosing scheme.
As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis. Receives: Drug: Fentanyl dosing schemes |
| Low-Dose Bolus of Fentanyl | Experimental | 5 minutes prior to sternotomy, patients will receive a fentanyl bolus of 3 mcg/kg BW (verum) and a perfusion pump with sodium chloride (NaCl 0.9%; placebo) will be begun according to the Shibutani dosing scheme.
As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis. Receives: Drug: Fentanyl dosing schemes |
| Continuous Dose of Fentanyl | Experimental | 5 minutes prior to sternotomy, patients will receive a NaCl 0.9% bolus (placebo) and a perfusion pump with fentanyl (verum) will be begun according to the Shibutani dosing scheme.
As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis. Receives: Drug: Fentanyl dosing schemes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of hyperalgesia at 24h
Determination of secondary, wound hyperalgesia by pin prick (256mN von Frey filament)
Measured: 24 hours after surgery (+/- 3 hours)
Secondary outcomes (21)
Area of hyperalgesia at 48h
Determination of secondary, wound hyperalgesia by pin prick (256mN von Frey filament)
Measured: 48 hours after surgery (+/- 3 hours)
Area of allodynia at 24h
Determination of allodynia by cotton swab
Measured: 24 hours after surgery (+/- 3 hours)
Area of allodynia at 48h
Determination of allodynia by cotton swab
Measured: 48 hours after surgery (+/- 3 hours)
Persistent Pain at 3 months
Validated questionnaire to assess pain after by1) mail and 2) phone follow-up
Measured: 3 months after surgery (+/- 1 week)
Persistent Pain at 6 months
Validated questionnaire to assess pain after by1) mail and 2) phone follow-up
Measured: 6 months after surgery (+/- 1 week)
Persistent Pain at 12 months
Validated questionnaire to assess pain after by1) mail and 2) phone follow-up
Measured: 12 months after surgery (+/- 1 week)
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run as specified by the time frame of this outcome and the following outcomes.
Measured: 5 min. (+/- 1 min) prior to sternotomy, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 5 min. (+/- 1 min) after fentanyl/placebo bolus, given just prior to sternotomy
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 30 min. (+/- 1 min) after fentanyl/placebo bolus, given just prior to sternotomy
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: just prior (<1min) to start of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 5 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 20 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 40 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 60 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 80 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 100 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 120 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 140 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 160 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: 5 min.(+/- 1 min) after end of pump run,a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Fentanyl will be measured from samples taken prior to, during, and after a pump run
Measured: end of surgery (+/- 5 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start14 May 2018
- Primary completion1 Feb 2020
- Study completion9 Jan 2021
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.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized, double-blinded, three arm study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450161
- Sponsor's protocol ID
- AGO/2017/005
- Other IDs
- 2017-003278-15, 2017
- Status last verified
- Sep 2024
- First submitted
- 29 Jan 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperalgesia, Persistent Pain, and Fentanyl Dosing in On-Pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03450161
- Acronym / sponsor ID
- AGO/2017/005
- Conditions
- Hyperalgesia, Opioid Use, Pain, Postoperative, Pain, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 14 May 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 1 Mar 2018 (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.
Randomized, double-blinded, three arm study in adult patients undergoing first time coronary artery bypass grafting (CABG) surgery with median sternotomy. The investigators will examine the effects of three fentanyl dosing schemes (high-dose bolus, low-dose bolus, continuous dose) on the area of hyperalgesia and allodynia at 24 and 48h as well as on persisting pain at 3, 6, and 12 months. Additionally, the investigators will measure fentanyl concentrations throughout anesthesia.
Detailed description
A prospective, randomized, double-blinded (patient, anesthesiologist, assessor) clinical study. This study will examine three different clinically used application schemes of fentanyl, an opioid used as the standard of care in routine practice. Patients will be randomized to receive one of the following three treatment arms for anesthesia maintenance (pre-sternotomy):
- High-dose fentanyl bolus (20 µg/kg of body weight [BW]; e.g. 70kg 1400 µg or 1.4mg)
- Low-dose fentanyl bolus (3 µg/kg BW; e.g. 70kg 210 µg or 0.2mg)
- Continuous fentanyl application by Shibutani scheme This study will include data from 69 adult patients (23 per arm) undergoing first time, elective, on-pump CABG surgery with median sternotomy and central cannulation. Following randomization by the sealed envelope technique, fentanyl kits will be drawn up by an anesthesiologist not involved in patient care or outcome assessment. Patients with preexisting chronic pain, opioids in the last 30 days, a BMI>36kg/m2, sleep apnoea, renal failure (clearance <30ml/min), with neuraxial anesthesia, pregnant, with planned wound infiltration, known allergies/intolerance to opioids, and unable to understand pin-prick testing will be excluded. At induction, all patients will receive a standard 3 µg/kg bolus of fentanyl (not study medication, but rather standard of care). 5 minutes prior to sternotomy, the patient will receive analgesia maintenance (one of the three fentanyl study arms). Clinicians will at all times be able to administer a bolus of fentanyl on a perceived "as needed" basis (not study medication, but rather standard of care). The primary objective of this trial is to assess whether or not different intraoperative dosing schemes of fentanyl during on-pump CABG surgery influence the area of hyperalgesia as measured by sternal pin-prick testing on the first postoperative day. As the mechanisms causing opioid-induced analgesia are poorly understood but appear to be dosis-related, the investigators will examine 3 clinically used fentanyl application schemes in cardiac surgery: 1) a high-dose bolus group, 2) a low-dose bolus group, and 3) a low-dose continuous infusion group. [i.e. does fentanyl dosing influence the area of hyperalgesia?] The secondary objectives of this trial are 1) to explore the intraoperative concentrations of fentanyl in these various dosing schemes during and after extracorporeal circulation (ECC). [i.e. determine the time course of fentanyl with ECC and its association with hyperalgesia; explorative] 2) to explore a possible association between fentanyl dosing, hyperalgesia, and persisting pain 3, 6, and 12 months after surgery. [i.e. clinical implication on persistent/chronic pain; explorative]
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blinded, three arm study
| Arm | Type | Receives |
|---|---|---|
| High-Dose Bolus of Fentanyl | Experimental | Drug: Fentanyl dosing schemes5 minutes prior to sternotomy, patients will receive a fentanyl bolus of 20 mcg/kg BW (verum) and a perfusion pump with sodium chloride (NaCl 0.9%; placebo) will be begun according to the Shibutani dosing scheme. As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis. |
| Low-Dose Bolus of Fentanyl | Experimental | Drug: Fentanyl dosing schemes5 minutes prior to sternotomy, patients will receive a fentanyl bolus of 3 mcg/kg BW (verum) and a perfusion pump with sodium chloride (NaCl 0.9%; placebo) will be begun according to the Shibutani dosing scheme. As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis. |
| Continuous Dose of Fentanyl | Experimental | Drug: Fentanyl dosing schemes5 minutes prior to sternotomy, patients will receive a NaCl 0.9% bolus (placebo) and a perfusion pump with fentanyl (verum) will be begun according to the Shibutani dosing scheme. As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consenting patients aged ≥18 years
- Undergoing first-time, elective, on-pump CABG surgery with median sternotomy and central cannulation.
Key exclusion criteria (9 listed)
- Documentation of preexisting chronic pain as per electronic record
- Use of opioids in the last 30 days or history/documentation of opioid abuse as per electronic record
- BMI > 35kg/m2 or history of obstructive sleep apnea syndrome
- Patients with renal failure (clearance < 30 ml/min)
- Neuraxial anesthesia
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 |
|---|---|---|
| Fentanyl dosing schemesWe routinely use fentanyl as the opioid of choice in CABG surgery. However, how much and whether or not to apply it in boli or continuously remain uncertain. We will apply 3 routinely used fentanyl dosing schemes in our hospital. To blind care-givers and patients, in each of the arms a bolus and a continous injection will occur, as delineated in the treatment arms. | Drug | Continuous Dose of Fentanyl, High-Dose Bolus of Fentanyl, Low-Dose Bolus of Fentanyl |
Primary outcome
Area of hyperalgesia at 24h
Time frame: 24 hours after surgery (+/- 3 hours)
Determination of secondary, wound hyperalgesia by pin prick (256mN von Frey filament)
21 secondary outcomes
Area of hyperalgesia at 48h
Time frame: 48 hours after surgery (+/- 3 hours)
Area of allodynia at 24h
Time frame: 24 hours after surgery (+/- 3 hours)
Area of allodynia at 48h
Time frame: 48 hours after surgery (+/- 3 hours)
Persistent Pain at 3 months
Time frame: 3 months after surgery (+/- 1 week)
Persistent Pain at 6 months
Time frame: 6 months after surgery (+/- 1 week)
Persistent Pain at 12 months
Time frame: 12 months after surgery (+/- 1 week)
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 5 min. (+/- 1 min) prior to sternotomy, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 5 min. (+/- 1 min) after fentanyl/placebo bolus, given just prior to sternotomy
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 30 min. (+/- 1 min) after fentanyl/placebo bolus, given just prior to sternotomy
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: just prior (<1min) to start of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 5 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 20 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 40 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 60 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 80 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 100 min. (+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 120 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 140 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 160 min.(+/- 1 min) after begin of pump run, a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: 5 min.(+/- 1 min) after end of pump run,a surgical step
Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation
Time frame: end of surgery (+/- 5 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
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 Fentanyl dosing schemes in people with Hyperalgesia and Opioid Use, run by University Hospital, Ghent at 1 site in Belgium.
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 9 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area of hyperalgesia at 24h (time frame: 24 hours after surgery (+/- 3 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 19 Sep 2024.