Pain, PostoperativePIPANCT03158753
Perfusion Index and Pain in Ankle Surgery
An observational study of Pain, Postoperative and Ankle Fractures, run by Rune Sort at 1 site in Denmark.
Trial summary
Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with activation of the sympathetic nervous system, such as by pain stimulation, as a result of involuntary contraction of the arterioles. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pain, Postoperative, Ankle Fractures
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Feb 2017to 31 May 2017
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the AnAnkle Trial at Herlev University Hospital.
Who may be able to join
- Scheduled for internal fixation of an ankle fracture
- Age > 18 years
- Ability to read and understand Danish and give informed written consent
Who cannot join
- Allergy towards NSAID, paracetamol, morphine or local anaesthetics
- Bodyweight < 52 kg; to avoid toxic doses of local anaesthetics
- Contraindications for SA
- Current gastro-intestinal bleeding
- Proximal fibular fracture or multitrauma / other simultaneous fractures
- Cognitive or psychiatric dysfunction or alcohol/narcotic substance abuse causing expected inability to comply with study protocol
Show all 13Show fewer
- No available anaesthesiologist with PNB capability at scheduled time of operation
- Neuropathy / neurological dysfunction in the lower extremities
- Habitual daily use of opioids
- Pregnancy or breastfeeding
- Infection at anaesthesia injection site
- Nephropathy requiring dialysis
- Acute porphyria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perfusion Index and Pain in Ankle Surgery - an Exploratory Study
Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with activation of the sympathetic nervous system, such as by pain stimulation, as a result of involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for "objective pain measurement", although its practical usefulness and dependability as such have not previously been investigated.
The investigators aim to explore associations between changes in PI and onset of pain following cessation of regional anaesthesia in alert patients following ankle fracture surgery.
Read more
Methods:
The investigators report an exploratory, observational analysis of prospectively gathered PI data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT: 2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive patients already included in the AnAnkle Trial at Herlev University Hospital, evenly distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB).
Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial and participants register pain scores on a 0-10 numeric rating scale every three hours and register the time of cessation of anaesthesia identified by return of sensation to the ankle. Morphine consumption is also registered.
The investigators will explore correlations of changes in PI to increases in pain upon cessation of the regional anaesthesia and, secondly, differences in cessation related PI changes with SA versus PNB.
Ethics:
All participants have already given informed, written consent for use of this data for the AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for initiation of AnAnkle Trial in July 2015.
- Conditions
- Pain, Postoperative, Ankle Fractures
- Medical subject headings
- Pain, Postoperative, Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
PI changes with rebound pain
Correlation of changes in PI to pain upon cessation of the regional anaesthesia
Measured: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Secondary outcomes (2)
PI changes in relation to anaesthesia modality
Differences in cessation related PI changes between spinal anaesthesia and PNBs
Measured: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Timing of PI changes
Exploration of timing of the PI changes related to patient reported cessation of regional anaesthesia.
Measured: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start2 Feb 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rune Sort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rune Sort, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158753
- Sponsor's protocol ID
- PIPA study
- Acronym
- PIPA
- Status last verified
- Feb 2018
- First submitted
- 3 May 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Index and Pain in Ankle Surgery - an Exploratory Study
- ClinicalTrials.gov ID
- NCT03158753
- Acronym / sponsor ID
- PIPA / PIPA study
- Conditions
- Pain, Postoperative, Ankle Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rune SortUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 18 May 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.
Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with activation of the sympathetic nervous system, such as by pain stimulation, as a result of involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for "objective pain measurement", although its practical usefulness and dependability as such have not previously been investigated.
The investigators aim to explore associations between changes in PI and onset of pain following cessation of regional anaesthesia in alert patients following ankle fracture surgery.
Methods:
The investigators report an exploratory, observational analysis of prospectively gathered PI data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT: 2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive patients already included in the AnAnkle Trial at Herlev University Hospital, evenly distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB).
Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial and participants register pain scores on a 0-10 numeric rating scale every three hours and register the time of cessation of anaesthesia identified by return of sensation to the ankle. Morphine consumption is also registered.
The investigators will explore correlations of changes in PI to increases in pain upon cessation of the regional anaesthesia and, secondly, differences in cessation related PI changes with SA versus PNB.
Ethics:
All participants have already given informed, written consent for use of this data for the AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for initiation of AnAnkle Trial in July 2015.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the AnAnkle Trial at Herlev University Hospital.
Key inclusion criteria (3 listed)
- Scheduled for internal fixation of an ankle fracture
- Age > 18 years
- Ability to read and understand Danish and give informed written consent
Key exclusion criteria (13 listed)
- Allergy towards NSAID, paracetamol, morphine or local anaesthetics
- Bodyweight < 52 kg; to avoid toxic doses of local anaesthetics
- Contraindications for SA
- Current gastro-intestinal bleeding
- Proximal fibular fracture or multitrauma / other simultaneous fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PI changes with rebound pain
Time frame: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Correlation of changes in PI to pain upon cessation of the regional anaesthesia
2 secondary outcomes
PI changes in relation to anaesthesia modality
Time frame: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Timing of PI changes
Time frame: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
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 27 Feb 2018.
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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?
An observational study of Pain, Postoperative and Ankle Fractures, run by Rune Sort at 1 site in Denmark.
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 13 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 27 Feb 2018. 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 Denmark. 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?
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?
PI changes with rebound pain (time frame: 1 hour prior to 6 hours post cessation of regional anaesthesia effect). 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 Feb 2018.