Rebound Pain Following Regional Anaesthesia for Ankle Fracture Surgery

NCT06864312 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-07

No results posted yet for this study

Summary

Regional anaesthesia is a commonly used and effective analgesic modality in orthopaedic surgery. The benefits of peripheral nerve blocks (PNB) include better pain relief, limited opioid consumption and high patient satisfaction(1-3).

Following ankle fracture surgery, rebound pain has been reported. The rebound effect was demonstrated in a randomised control trial comparing pain after ankle fracture repair under general anaesthesia with or without PNB(4). An increase in pain scores was demonstrated after PNB resolution exceeding that of the group without PNB. Prospective research from Cork University Hospital (CUH) in recent years has identified rebound pain as a clinically significant issue. 2018 CUH data have demonstrated that pain following ankle fracture surgery is well managed by PNB, with no reported pain until block regression(5). Upon block regression (12-18 hours postoperatively), the median pain score was 8 out of 10 on the numerical rating scale. Median peak pain score across all patients in the first 24 hours after block administration was 7.5.

Acute postoperative pain is an important problem due to negative patient consequences which include: increased morbidity; impaired physical function; prolonged hospital stay; and persistent pain. Studies to evaluate solutions to rebound pain are lacking. Favourable outcomes may be obtained with either continuous PNB(6) and timed systemic analgesics. Formal evaluation of such bespoke analgesic pathways is required.

We aim to establish an evidence-based strategy to prevent rebound pain. On a patient level, this would reduce the patient's experience of severe acute postoperative pain. This would improve a myriad of short- and long- term patient factors including; patient experience, opioid requirement, mobility, length of stay, chronic pain(7, 8). Rebound pain has additionally been reported following upper limb surgery(9). The knowledge generated by this study also has the potential to impact the postoperative analgesic management of upper limb fracture surgeries. This study aims to answer an original research question which has not been addressed in the literature to-date.

Conditions

  • Ankle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar)
  • Ankle Fracture - Lateral Malleolus
  • Ankle Fracture - Medial Malleolus
  • Rebound Pain

Interventions

DRUG

continuous infusion of levobupivacaine

patients one arm of this study will receive a postoperative continuous infusion of levobupivacaine

DRUG

oxycodone

A timed weight appropriate dose of oxycodone will be administered 16 hours postoperatively

Sponsors & Collaborators

  • Cork University Hospital

    collaborator OTHER
  • University College Cork

    lead OTHER

Principal Investigators

  • Brian D O'Donnell, MBBChBAO MSc FCARCSI MD · Cork University Hospital & University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2025-01-28
Completion
2025-01-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864312 on ClinicalTrials.gov