Clinical trial NCT02100098: Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
Official title: Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Ankle fracture
Nerve block
Postoperative pain
Pain profile
Rebound pain
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
Secondary outcomes:
measure: Opioid use 12-24 hours compared to 0-12 hours postoperatively
timeFrame: 0-24 hours continuous measurement
measure: Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively
timeFrame: 0-24 hours postoperatively
measure: Time to first opioid dose postoperatively
timeFrame: 0-24 hours postoperatively
measure: Time to patient estimated cessation of block effect
timeFrame: 0-24 hours postoperatively
measure: NRS day 1-7 as both "average" and "worst" of the day
timeFrame: Days 1-7 postoperatively
measure: Daily opioid consumption day 1-7
timeFrame: Days 1-7 postoperatively
Other outcomes:
measure: 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.
timeFrame: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
measure: Score of the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and on postoperative day 1.
timeFrame: Preoperatively and postoperative day 1
measure: QoR-15 questionnaire score on day 1, 2 and 7 postoperatively
timeFrame: Postoperative day 1, 2 and 7.
measure: Length of postoperative stay in hospital
timeFrame: Up to 3 weeks
measure: Time to first meal/appetite postoperatively
timeFrame: 0-24 hours postoperatively
measure: Incidence of postoperative nerve symptoms (PONS) on day 7
timeFrame: Postoperative day 7
measure: Postoperative nausea and vomiting (PONV) 24 hours postoperatively
timeFrame: 0-24 hours postoperatively
measure: Antiemetic medication 24h postoperatively
timeFrame: 0-24 hours postoperatively
measure: Time used for PNB administration
timeFrame: Preoperatively
measure: Time to PNB effect on sensory and motor function
timeFrame: Preoperatively
measure: Length of stay in the Operation Room (OR) - total and pre- and post-operatively
timeFrame: Operation day
measure: Duration of surgery
timeFrame: Operation day
measure: Partial block rate and Failed block rate
timeFrame: Operation day
measure: Need for PACU admission postoperatively
timeFrame: Operation day
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Department of Anaesthesiology, Herlev Hospital
name: Rune Sort, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, Herlev Hospital
name: Ann M Møller, Prof., DMSc
role: STUDY_DIRECTOR
References:
citation: 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.