Clinical trial NCT06886815: Popliteal Nerve Block for Achilles Tendon Repair Surgery
Official title: The Effect of Popliteal Nerve Block on Recovery After Achilles Tendon Repair Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Regional Anesthesia
Nerve Block
Achilles Tendon Rupture
Achilles Tendon Surgery
Keywords: Popliteal Nerve Block
Popliteal Block
Lower Extremity Regional Anesthesia
Achilles Tendon
Ambulatory Surgery
Peripheral Nerve Injury
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients aged 18 - 65, with an ASA classification of I - III and a BMI of \< 35 mg/kg\^2, and undergoing ambulatory Achilles tendon repair surgery will be eligible for inclusion.
Primary purpose: TREATMENT

Brief summary: Surgery has traditionally been the mainstay of treatment for patients who experience acute Achilles tendon rupture, and anesthesia for this operation often includes a popliteal nerve block. However, the evidence basis for this practice is uncertain, and popliteal nerve block has associated risks such as peripheral nerve injury. This research study will evaluate the effects of popliteal nerve block on postoperative pain, recovery, and quality of life after Achilles tendon repair surgery, in order to better inform patient and provider decisions to receive or perform popliteal nerve block for this operation.

Detailed description: This research study will evaluate the effectiveness and safety of popliteal nerve block as an adjunct analgesic technique for Achilles tendon repair surgery. The protocol describes a prospective, double-blinded, randomized, and sham-controlled superiority trial conducted at Women's College Hospital in Toronto, Ontario, Canada.

Eligible and consenting patients will be randomized into study groups by a computer-generated sequence. Investigators and participants will both be blinded to patient assignment at the time of randomization as well as throughout treatment and assessment. Study groups will receive either a standard popliteal nerve block performed immediately before their surgery in the popliteus of the surgical knee, or a sham block with normal saline. Patients in both groups will receive preoperative and postoperative multi-modal analgesia management as per our institution's standard practice, and will be administered a general anesthetic in the prone position during their surgery.

Following Achilles tendon repair, data will be collected pertaining to patient pain, quality of life, recovery, and adverse events in the acute and subacute postoperative periods (in-hospital as well as through the use of a study diary following discharge home). Data from study groups will be compared to elucidate risks and benefits attributable to popliteal nerve block, in order to inform patient and provider decision-making in the perioperative period.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 65
* ASA classification: I - III
* BMI \< 35 kg/m2
* Undergoing acute Achilles tendon 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)
* Chronic pain disorders
* 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

Primary outcomes:
measure: Cumulative Opioid Consumption
timeFrame: The first 24 hours after surgery.
Secondary outcomes:
measure: Area Under the Curve for Postoperative Pain
timeFrame: The first 24 hours after surgery.
measure: Quality of Recovery
timeFrame: Measured at 6, 24, and 48 hours after surgery, as well as 7 days after surgery.
measure: Postoperative Pain Score
timeFrame: Assessed at 0, 6, 12, 18, 24, 36, and 48 hours after surgery, as well as 7 days after surgery.
measure: Intraoperative Opioid Consumption
timeFrame: During Achilles tendon repair surgery.
measure: Time to Analgesic Request
timeFrame: The first 24 hours after surgery.
measure: Time to Discharge
timeFrame: The first 24 hours after surgery.
measure: Adverse Events Attributable to Popliteal Block
timeFrame: Until final follow-up (one week postoperative).
measure: Adverse Events Attributable to Opioids
timeFrame: Evaluated at 24 and 48 hours after surgery.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Richard Brull, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.