Rebound Pain Following Regional Anaesthesia for Ankle Fracture Surgery

NCT06864312 | Completed Phase 4 DMC

• 1 other identifier: ANKLE 2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rebound Pain; Ankle Fracture; Regional Anaesthesia; Nerve Block; Analgesia

Outcome Measures

Primary Outcomes (1)

• Rebound Pain

  Patient reported pain on a 11 point (0-10) verbal rating pain scale upon regression of popliteal sciatic block or pain measured at a time point between 17-24 hours following the ankle fracture surgery.

  17-24 hours following the ankle fracture surgery

Study Arms (3)

Control

NO INTERVENTION

Patients randomised to this group will receive the current 'gold standard' of post operative analgesic care: Popliteal Fossa Sciatic Block with standard postoperative multimodal analgesia

Intervention Continuous Popliteal Fossa Sciatic Block

EXPERIMENTAL

Patients randomised to this group will receive standard of post operative analgesic care: Popliteal Fossa Sciatic Block with standard postoperative multimodal analgesia, together with a paraneural sciatic catheter placed at the time of block and used for the continuous postoperative administration of local anaesthetic

Drug: continuous infusion of levobupivacaine

Intervention Timed opioid

EXPERIMENTAL

Patients randomised to this group will receive standard of post operative analgesic care: Popliteal Fossa Sciatic Block with standard postoperative multimodal analgesia, together with a timed (to coincide with expected nerve block offset) and weight appropriate dose of immediate release oxycodone.

Drug: oxycodone

Interventions

continuous infusion of levobupivacaine DRUG

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

Intervention Continuous Popliteal Fossa Sciatic Block

oxycodone DRUG

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

Intervention Timed opioid

Eligibility Criteria

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

You may qualify if:

• Patients undergoing surgery for ankle fracture ORIF receiving regional anaesthesia for postoperative analgesia.
• ASA Grades 1-3

You may not qualify if:

• Pain preoperatively of any source requiring analgesic consumption (on more than three occasions) within three months of surgery.
• Open fractures Multiple injuries History of chronic pain syndrome. History of peripheral neuropathy. Clinically significant cognitive impairment (MiniMental state score \< 24) Severe cardiac, respiratory, renal or endocrine dysfunction Allergy to any of the following: Lignocaine, Bupivacaine, Paracetamol, Diclofenac, Oxycodone, Dexamethasone, Propofol, Vecuronium.
• Malignant Hyperthermia

Sponsors & Collaborators

• University College Cork: lead
• Cork University Hospital: collaborator

Study Sites (1)

Cork University Hospital

Cork, Cork, P85 FR62, Ireland

Location

MeSH Terms

Conditions

Ankle Fractures; Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Brian D O'Donnell, MBBChBAO MSc FCARCSI MD

  Cork University Hospital & University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist and Clinical Senior Lecturer

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: October 16, 2023
• Primary Completion: January 28, 2025
• Study Completion: January 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

IE (1)