Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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

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Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Existing neuropathy with functional impairment of the fractured extremity
* Bodyweight \< 50 kg
* Daily use of opioids \> 2 weeks preoperatively
* Pregnancy
* Nephropathy requiring dialysis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No