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

NCT02100098 | Completed

• 1 other identifier: PAnFractRebound-01
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Ankle fracture; Nerve block; Postoperative pain; Pain profile; Rebound pain

Outcome Measures

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.

  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

Secondary Outcomes (6)

• Opioid use 12-24 hours compared to 0-12 hours postoperatively

  0-24 hours continuous measurement

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

  0-24 hours postoperatively

• 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

Other Outcomes (14)

• 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

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

  Preoperatively and postoperative day 1

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

  Postoperative day 1, 2 and 7.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, Denmark, DK-2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30411313 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Rune Sort, MD

  Department of Anaesthesiology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

• Ann M Møller, Prof., DMSc

  Department of Anaesthesiology, Herlev Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research Fellow

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 20, 2015

Record last verified: 2015-04

Locations

DK (1)