Herlev Hospital
Herlev, DK-2730, Denmark
NCT Number: NCT03158753
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.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Observational
Herlev, DK-2730, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Differences in cessation related PI changes between spinal anaesthesia and PNBs
Time frame: 1 hour prior to 6 hours post cessation of regional anaesthesia effect
Exploration of timing of the PI changes related to patient reported cessation of regional anaesthesia.
Rune Sort
Other
Perfusion Index and Pain in Ankle Surgery - an Exploratory Study
Acronym: PIPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05494645
Ankle Fractures, Ankle Injuries
Bethlehem, Pennsylvania, United States
View Trial DetailsNCT02967172
Ankle Fractures, Ankle Injuries
Iowa City, Iowa, United States
View Trial DetailsNCT02949674
Ankle Fractures, Ankle Injuries
Mexico City, Mexico
View Trial DetailsNCT06949826
Ankle Fracture Surgery, Ankle Fractures
St Louis, Missouri, United States
View Trial Details