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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100098
• Other study ID #: PAnFractRebound-01
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: April 17, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankle Fractures
• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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.	0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively	No
Other	Score of the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and on 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.	Preoperatively and postoperative day 1	No
Other	QoR-15 questionnaire score on day 1, 2 and 7 postoperatively		Postoperative day 1, 2 and 7.	No
Other	Length of postoperative stay in hospital		Up to 3 weeks	No
Other	Time to first meal/appetite postoperatively		0-24 hours postoperatively	No
Other	Incidence of postoperative nerve symptoms (PONS) on day 7	Telephone interview	Postoperative day 7	No
Other	Postoperative nausea and vomiting (PONV) 24 hours postoperatively		0-24 hours postoperatively	No
Other	Antiemetic medication 24h postoperatively		0-24 hours postoperatively	No
Other	Time used for PNB administration		Preoperatively	No
Other	Time to PNB effect on sensory and motor function		Preoperatively	No
Other	Length of stay in the Operation Room (OR) - total and pre- and post-operatively		Operation day	No
Other	Duration of surgery		Operation day	No
Other	Partial block rate and Failed block rate	Partial = need for supplemental block preoperatively (if PNB seems insufficient after 30 min). Failed = need for General Anaesthesia.	Operation day	No
Other	Need for PACU admission postoperatively	Most patients are expected to be send directly to the Orthopaedic ward following surgery. If not, the reason is noted.	Operation day	No
Primary	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).	0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively	No
Secondary	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.	0-24 hours continuous measurement	No
Secondary	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.	0-24 hours postoperatively	No
Secondary	Time to first opioid dose postoperatively		0-24 hours postoperatively	No
Secondary	Time to patient estimated cessation of block effect		0-24 hours postoperatively	No
Secondary	NRS day 1-7 as both "average" and "worst" of the day	NRS are filled out by the patient in a diary.	Days 1-7 postoperatively	No
Secondary	Daily opioid consumption day 1-7	Registered in a diary.	Days 1-7 postoperatively	No