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NCT Number: NCT02100098

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

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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Key information

Conditions

Postoperative Pain Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev Hospital

Herlev, Denmark, DK-2730

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Opioid use 12-24 hours compared to 0-12 hours postoperatively

    Time frame: 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.

  2. Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively

    Time frame: 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.

  3. Time to first opioid dose postoperatively

    Time frame: 0-24 hours postoperatively

  4. Time to patient estimated cessation of block effect

    Time frame: 0-24 hours postoperatively

  5. NRS day 1-7 as both "average" and "worst" of the day

    Time frame: Days 1-7 postoperatively

    NRS are filled out by the patient in a diary.

  6. Daily opioid consumption day 1-7

    Time frame: Days 1-7 postoperatively

    Registered in a diary.

Other outcomes

  1. 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.

    Time frame: 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.

  2. Score of the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and on postoperative day 1.

    Time frame: 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.

  3. QoR-15 questionnaire score on day 1, 2 and 7 postoperatively

    Time frame: Postoperative day 1, 2 and 7.

  4. Length of postoperative stay in hospital

    Time frame: Up to 3 weeks

  5. Time to first meal/appetite postoperatively

    Time frame: 0-24 hours postoperatively

  6. Incidence of postoperative nerve symptoms (PONS) on day 7

    Time frame: Postoperative day 7

    Telephone interview

  7. Postoperative nausea and vomiting (PONV) 24 hours postoperatively

    Time frame: 0-24 hours postoperatively

  8. Antiemetic medication 24h postoperatively

    Time frame: 0-24 hours postoperatively

  9. Time used for PNB administration

    Time frame: Preoperatively

  10. Time to PNB effect on sensory and motor function

    Time frame: Preoperatively

  11. Length of stay in the Operation Room (OR) - total and pre- and post-operatively

    Time frame: Operation day

  12. Duration of surgery

    Time frame: Operation day

  13. Partial block rate and Failed block rate

    Time frame: Operation day

    Partial = need for supplemental block preoperatively (if PNB seems insufficient after 30 min). Failed = need for General Anaesthesia.

  14. Need for PACU admission postoperatively

    Time frame: Operation day

    Most patients are expected to be send directly to the Orthopaedic ward following surgery. If not, the reason is noted.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Mar 31, 2014
Registry last updated
Apr 20, 2015

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.

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