Acute Achilles Tendon Rupture
Conditions
Keywords
Popliteal Nerve Block, Lower Extremity Regional Anesthesia, Achilles Tendon
Brief summary
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
PROCEDUREPopliteal 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.
PROCEDURESham 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 by patients with knowledge of the technique.
Sponsors
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
As noted above, only the individual administering the intervention will be aware of allocation assignment. The participant and outcomes assessors will be blinded to minimize bias.
Intervention model description
This study will be a prospective, double-blinded, randomized controlled superiority trial with two parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Opioid Consumption | The first 24 hours after surgery | Total opioid dose administered to each patient, converted to oral morphine equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve for Postoperative Pain | The first 24 hours after surgery | Area under the curve calculated from discrete Numeric Rating Scale evaluations of postoperative pain (0 - 10), where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable. Pain will be measured on this scale at 0, 6, 12, 18, and 24 hours after surgery. |
| Quality of Recovery | At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery | Quality of recovery evaluated using the QoR-15 scale (0 - 150), where 0 represents extremely poor recovery and 150 represents excellent recovery. |
| Postoperative Pain Score | At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery. | Measured using the Numeric Rating (NRS) Scale (0 - 10) where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable. |
| Intraoperative Opioid Consumption | The first 24 hours after surgery | Measurement of opioids administered during surgery, converted into oral morphine equivalents. |
| Time to Analgesic Request | The first 24 hours after surgery | Length of time until the patient's first request for analgesics following surgery. |
| Time to Discharge | The first 24 hours after surgery | The length of time each patient stays in Phase I (Postanesthesia Care Unit) and Phase II (Surgical Day Care) after surgery. |
| Adverse Events Attributable to Popliteal Block | At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery | The incidence of adverse events possibly attributable to popliteal nerve block, including peripheral nerve injury, hematoma, and infection. |
| Adverse Events Attributable to Opioids | Evaluated at 24 and 48 hours after surgery. | The incidence of opioid-related side effects, including sedation, pruritis, nausea/vomiting, and respiratory depression. |
| Pain, fatigue, and physical function | Prior to surgery and 1-year post-surgery | Measured using the Achilles tendon Total Rupture Score (ATRS) |
| Neuropathic pain | At 1 week and 1-year post-surgery | Measured using the English version of the Douleur Neuropathique 4 (DN4) Questionnaire |
Countries
Canada
Contacts
CONTACTDidem Bozak
PRINCIPAL_INVESTIGATORRichard Brull, MD, FRCPC
University Health Network, Toronto
Outcome results
None listed