Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
Study Details
Study Description
Brief 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. 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.
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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
Outcome Measures
Primary Outcome Measures
- 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. [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).
Secondary Outcome Measures
- Opioid use 12-24 hours compared to 0-12 hours postoperatively [0-24 hours continuous measurement]
Rescue morphine doses are administered intravenously via a patient controlled analgesia (PCA) pump when needed. Times of use are electronically registered.
- Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively [0-24 hours 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.
- Time to first opioid dose postoperatively [0-24 hours postoperatively]
- Time to patient estimated cessation of block effect [0-24 hours postoperatively]
- NRS day 1-7 as both "average" and "worst" of the day [Days 1-7 postoperatively]
NRS are filled out by the patient in a diary.
- Daily opioid consumption day 1-7 [Days 1-7 postoperatively]
Registered in a diary.
Other Outcome Measures
- Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) after cessation of nerve block compared to before cessation of nerve block. [0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively]
The average postoperative time to cessation of nerve block defining the time periods for this comparison will be defined after visual evaluation of the given pain profiles.
- Score of the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and on postoperative day 1. [Preoperatively and postoperative day 1]
Validation of the Danish translation of QoR-15 in this population of patients undergoing acute orthopaedic surgery under PNB-anaesthesia. A Danish version of the QoR-15 questionnaire is currently being validated in a mixed surgical patient population receiving surgery under general anaesthesia. We will attempt to validate the questionnaire on patients receiving nerve block (PNB) anaesthesia.
- QoR-15 questionnaire score on day 1, 2 and 7 postoperatively [Postoperative day 1, 2 and 7.]
- Length of postoperative stay in hospital [Up to 3 weeks]
- Time to first meal/appetite postoperatively [0-24 hours postoperatively]
- Incidence of postoperative nerve symptoms (PONS) on day 7 [Postoperative day 7]
Telephone interview
- Postoperative nausea and vomiting (PONV) 24 hours postoperatively [0-24 hours postoperatively]
- Antiemetic medication 24h postoperatively [0-24 hours postoperatively]
- Time used for PNB administration [Preoperatively]
- Time to PNB effect on sensory and motor function [Preoperatively]
- Length of stay in the Operation Room (OR) - total and pre- and post-operatively [Operation day]
- Duration of surgery [Operation day]
- Partial block rate and Failed block rate [Operation day]
Partial = need for supplemental block preoperatively (if PNB seems insufficient after 30 min). Failed = need for General Anaesthesia.
- Need for PACU admission postoperatively [Operation day]
Most patients are expected to be send directly to the Orthopaedic ward following surgery. If not, the reason is noted.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above.
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Ability to read and understand Danish and give informed oral and written consent
Exclusion Criteria:
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Multitrauma patients / other simultaneous fractures
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Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol
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"CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason
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Primary investigator unavailable for PNB administration at scheduled time of operation
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Infection at PNB injection site
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Time from fracture to operation > 5 days
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Existing neuropathy with functional impairment of the fractured extremity
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Bodyweight < 50 kg
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Daily use of opioids > 2 weeks preoperatively
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Pregnancy
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Nephropathy requiring dialysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Herlev Hospital | Herlev | Denmark | DK-2730 |
Sponsors and Collaborators
- Herlev Hospital
Investigators
- Principal Investigator: Rune Sort, MD, Department of Anaesthesiology, Herlev Hospital
- Study Director: Ann M Møller, Prof., DMSc, Department of Anaesthesiology, Herlev Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PAnFractRebound-01