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Recruiting NCT06886815

Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery

No phase Interventional Acute Achilles Tendon Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Popliteal Nerve Block, Sham Block.
Who it may be relevant to
Registry conditions: Acute Achilles Tendon Rupture. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial

Overview

Achilles tendon rupture is common, yet the value of popliteal nerve block for postoperative pain control during surgical repair remains uncertain. Despite widespread use, evidence supporting its analgesic effectiveness is limited, and both popliteal nerve block and Achilles tendon repair carry risks of nerve injury. This randomized, placebo-controlled trial will evaluate whether adding a popliteal nerve block to standard systemic analgesia improves postoperative pain and reduces opioid use in patients undergoing acute Achilles tendon rupture repair. Secondary outcomes will examine the incidence and impact of nerve complications on recovery, including return to physical activity and functional performance.

Detailed description

This will be a prospective, double-blinded, randomized controlled superiority trial conducted at Women's College Hospital (WCH). The study aims to enroll 80 patients (40 per group) undergoing ambulatory surgical repair of acute Achilles tendon ruptures.

Interventions

  • Procedure Popliteal Nerve Block
    Under ultrasound guidance, a 22G, 80-mm echogenic needle (SonoTAP II, Pajunk Medical Systems, USA) will be inserted using an in-plane lateral-to-medial approach. 30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine will be deposited between tibial and common peroneal nerves within the paraneural sheath. Adequate spread of local anesthetics will be confirmed by visualization of paraneural spread.
  • Procedure Sham Block
    Patients in the Control group will receive sham blocks using a 25G needle to inject 1 mL of saline subcutaneously in the same location (popliteus of the surgical knee). Sterilization and ultrasound scanning will match actual PN block. Such a non-invasive placebo allows maintaining patient blinding, while reducing the risks associated with high-volume placebo nerve block injections. The ultrasound screen will be blinded from the patient's vision for all patients in the trial to prevent unblinding

Primary outcome measures

  • Cumulative Opioid Consumption [Time frame: The first 24 hours after surgery]
Secondary outcome measures (10)
  • Area Under the Curve for Postoperative Pain [Time frame: The first 24 hours after surgery]
  • Quality of Recovery [Time frame: At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery]
  • Postoperative Pain Score [Time frame: At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.]
  • Intraoperative Opioid Consumption [Time frame: The first 24 hours after surgery]
  • Time to Analgesic Request [Time frame: The first 24 hours after surgery]
  • Time to Discharge [Time frame: The first 24 hours after surgery]
  • Adverse Events Attributable to Popliteal Block [Time frame: At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery]
  • Adverse Events Attributable to Opioids [Time frame: Evaluated at 24 and 48 hours after surgery.]
  • Pain, fatigue, and physical function [Time frame: Prior to surgery and 1-year post-surgery]
  • Neuropathic pain [Time frame: At 1 week and 1-year post-surgery]

Eligibility criteria

Inclusion criteria

  • Age 18 - 65
  • ASA classification: I - III
  • BMI < 35 kg/m2
  • Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure

Exclusion criteria

  • Pre-existing neurological deficits or peripheral neuropathy in the distribution of the tibial or common peroneal nerves
  • Local infection
  • Contraindication to regional anesthesia (e.g., bleeding diathesis, coagulopathy)
  • History of use of over 30 mg oxycodone or equivalent per day
  • Contraindication to any component of a standard multi-modal analgesia
  • Allergy to local anesthetics
  • History of significant psychiatric conditions that may affect patient assessment
  • Pregnancy
  • Inability to provide informed consent
  • Patient refusal of popliteal nerve blockade
  • Prior Achilles tendon surgeries on the operative leg
  • Unable to speak or read English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Women's College Hospital — Toronto

Publications

  • Brenna CTA, Khan S, Abdallah FW, Brull R. Achilles Hero or Heel? A Systematic Review of Popliteal Nerve Block for Achilles Repair. Foot & Ankle Surgery: Techniques, Reports & Cases. 2025:100474.

Identifiers

NCT: NCT06886815 · 2025-0039-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗