Postoperative PainNCT02100098
Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
An observational study of Postoperative Pain, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for internal fixation of an ankle fracture under PNB-anaesthesia at Herlev Hospital identified from the operation booking system via consecutive screening. Eligible ankle fractures will be those of anatomically uni-, bi- or trimalleolar composition including syndesmotic injury with distal but not proximal fibular fracture. The "third malleolus" is the distal posterior edge of the tibia. Fractures needing external fixation or causing ankle dislocation in need of imminent surgery is not eligible.
Who may be able to join
- Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above.
- Ability to read and understand Danish and give informed oral and written consent
Who cannot join
- Multitrauma patients / other simultaneous fractures
- Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol
- "CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason
- Primary investigator unavailable for PNB administration at scheduled time of operation
- Infection at PNB injection site
- Time from fracture to operation > 5 days
Show all 11Show fewer
- Existing neuropathy with functional impairment of the fractured extremity
- Bodyweight < 50 kg
- Daily use of opioids > 2 weeks preoperatively
- Pregnancy
- Nephropathy requiring dialysis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block.
Results are used to guide the set up of a randomized controlled trial on the subject.
Read the detailed description
Peripheral nerve blocks (PNB) are widely used as anaesthesia and postoperative pain control for surgery. Several studies have suggested multiple benefits of PNB's but primarily shown in elective surgery. Acute conditions like ankle fractures have a different pain profile and risks and benefits of PNB's have not been sufficiently researched in these cases.
A recent study (Goldstein et al. 2012) suggested that a rebound pain effect occur upon cessation of PNB effect defined as a pain increase to a significantly higher level than observed in patients with no PNB at the same point after surgery.
With this prospective, exploratory study we aim to examine the postoperative pain profile after PNB anaesthesia for ankle fracture surgery with focus on plausibility of a rebound pain effect (as defined above) upon PNB cessation.
Secondarily to explore a variety of factors related to postoperative pain profile and feasibility of PNB anaesthesia for ankle surgery including efficacy, risk factors, time factors as well as postoperative recovery and overall patient satisfaction. Results will provide focus for a following randomized controlled trial.
- Conditions
- Postoperative Pain
- Keywords
- Ankle fracture, Nerve block, Postoperative pain, Pain profile, Rebound pain
- Medical subject headings
- Pain, Postoperative, Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) for the time period 12-24 hours compared to 0-12 hours postoperatively.
Pain scores are assessed and marked by the patient on a 0-10 numeric rating pain scale (NRS).
Measured: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
Secondary outcomes (6)
Opioid use 12-24 hours compared to 0-12 hours postoperatively
Rescue morphine doses are administered intravenously via a patient controlled analgesia (PCA) pump when needed. Times of use are electronically registered.
Measured: 0-24 hours continuous measurement
Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively
We will calculate the "Silverman" composite score of opioid use and pain score combined. This in order to illustrate any increase in pain and to use for sample size calculations for a future randomised study on the subject.
Measured: 0-24 hours postoperatively
Time to first opioid dose postoperatively
Measured: 0-24 hours postoperatively
Time to patient estimated cessation of block effect
Measured: 0-24 hours postoperatively
NRS day 1-7 as both "average" and "worst" of the day
NRS are filled out by the patient in a diary.
Measured: Days 1-7 postoperatively
Daily opioid consumption day 1-7
Registered in a diary.
Measured: Days 1-7 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rune Sort, Herlev Hospital
- Investigators
- Rune Sort, MD, Principal investigator, Department of Anaesthesiology, Herlev HospitalAnn M Møller, Prof., DMSc, Study director, Department of Anaesthesiology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100098
- Sponsor's protocol ID
- PAnFractRebound-01
- Status last verified
- Apr 2015
- First submitted
- 24 Mar 2014
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sort R, Brorson S, Gogenur I, Nielsen JK, Moller AM. Rebound pain following peripheral nerve block anaesthesia in acute ankle fracture surgery: An exploratory pilot study. Acta Anaesthesiol Scand. 2019 Mar;63(3):396-402. doi: 10.1111/aas.13290. Epub 2018 Nov 8.
PubMed 30411313
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
- ClinicalTrials.gov ID
- NCT02100098
- Acronym / sponsor ID
- PAnFractRebound-01
- Conditions
- Postoperative Pain
- Keywords
- Ankle fracture, Nerve block, Postoperative pain, Pain profile, Rebound pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Mar 2014 (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.
The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block.
Results are used to guide the set up of a randomized controlled trial on the subject.
Detailed description
Peripheral nerve blocks (PNB) are widely used as anaesthesia and postoperative pain control for surgery. Several studies have suggested multiple benefits of PNB's but primarily shown in elective surgery. Acute conditions like ankle fractures have a different pain profile and risks and benefits of PNB's have not been sufficiently researched in these cases.
A recent study (Goldstein et al. 2012) suggested that a rebound pain effect occur upon cessation of PNB effect defined as a pain increase to a significantly higher level than observed in patients with no PNB at the same point after surgery.
With this prospective, exploratory study we aim to examine the postoperative pain profile after PNB anaesthesia for ankle fracture surgery with focus on plausibility of a rebound pain effect (as defined above) upon PNB cessation.
Secondarily to explore a variety of factors related to postoperative pain profile and feasibility of PNB anaesthesia for ankle surgery including efficacy, risk factors, time factors as well as postoperative recovery and overall patient satisfaction. Results will provide focus for a following randomized controlled trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for internal fixation of an ankle fracture under PNB-anaesthesia at Herlev Hospital identified from the operation booking system via consecutive screening. Eligible ankle fractures will be those of anatomically uni-, bi- or trimalleolar composition including syndesmotic injury with distal but not proximal fibular fracture. The "third malleolus" is the distal posterior edge of the tibia. Fractures needing external fixation or causing ankle dislocation in need of imminent surgery is not eligible.
Key inclusion criteria (2 listed)
- Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above.
- Ability to read and understand Danish and give informed oral and written consent
Key exclusion criteria (11 listed)
- Multitrauma patients / other simultaneous fractures
- Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol
- "CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason
- Primary investigator unavailable for PNB administration at scheduled time of operation
- Infection at PNB injection site
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
Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) for the time period 12-24 hours compared to 0-12 hours postoperatively.
Time frame: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
Pain scores are assessed and marked by the patient on a 0-10 numeric rating pain scale (NRS).
6 secondary outcomes
Opioid use 12-24 hours compared to 0-12 hours postoperatively
Time frame: 0-24 hours continuous measurement
Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively
Time frame: 0-24 hours postoperatively
Time to first opioid dose postoperatively
Time frame: 0-24 hours postoperatively
Time to patient estimated cessation of block effect
Time frame: 0-24 hours postoperatively
NRS day 1-7 as both "average" and "worst" of the day
Time frame: Days 1-7 postoperatively
Daily opioid consumption day 1-7
Time frame: Days 1-7 postoperatively
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 20 Apr 2015.
- Derived from this study: PubMed 30411313Sort R, Brorson S, Gogenur I, Nielsen JK, Moller AM. Rebound pain following peripheral nerve block anaesthesia in acute ankle fracture surgery: An exploratory pilot study. Acta Anaesthesiol Scand. 2019 Mar;63(3):396-402. doi: 10.1111/aas.13290. Epub 2018 Nov 8.
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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.
Rune Sort, MD principal investigator
Department of Anaesthesiology, Herlev Hospital
Ann M Møller, Prof., DMSc study director
Department of Anaesthesiology, Herlev Hospital
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 Postoperative Pain, run by Herlev Hospital 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 2 inclusion and 11 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 20 Apr 2015. 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?
Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) for the time period 12-24 hours compared to 0-12 hours postoperatively. (time frame: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100098, which also lists 1 linked publication.
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 20 Apr 2015.