Popliteal Nerve Block for Achilles Tendon Repair Surgery

University of Toronto

Status: Begins enrollment in 4 months

Conditions: Achilles Tendon Rupture; Nerve Block; Achilles Tendon Surgery; Regional Anesthesia

Treatments: Procedure: Popliteal Nerve Block; Procedure: Sham Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06886815

PB-ATR-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Popliteal Nerve Block Group

Experimental group

Description:

Patients will be randomly assigned to this, or a comparator, group. In accordance with routine pre-block management, non-invasive blood pressure, electrocardiogram, and pulse oximeter will be attached to the patient. A 20G intravenous access will be secured in the upper extremity to begin administering an intravenous infusion of Lactated Ringer's solution. Prior to block performance, all patients will receive intravenous midazolam 1 - 4 mg IV for anxiolysis. In a designated block room, a regional anesthesiologist or anesthesia fellow with experience performing popliteal nerve blocks will sterilize the popliteus of the surgical knee with 2% chlorhexidine swabs, infiltrate it with 2 mL 2% lidocaine, and visualize the underlying anatomy using ultrasound. They will then perform a popliteal nerve block for patients in this group. Patients in both groups will otherwise receive identical preoperative and postoperative care.

Treatment:

Procedure: Popliteal Nerve Block

Control Group

Sham Comparator group

Description:

Patients will be randomly assigned to this, or an intervention, group. In accordance with routine pre-block management, non-invasive blood pressure, electrocardiogram, and pulse oximeter will be attached to the patient. A 20G intravenous access will be secured in the upper extremity to begin administering an intravenous infusion of Lactated Ringer's solution. Prior to block performance, all patients will receive intravenous midazolam 1 - 4 mg IV for anxiolysis. In a designated block room, a regional anesthesiologist or anesthesia fellow with experience performing popliteal nerve blocks will sterilize the popliteus of the surgical knee with 2% chlorhexidine swabs, infiltrate it with 2 mL 2% lidocaine, and visualize the underlying anatomy using ultrasound. They will then perform a sham block for patients in this group. Patients in both groups will otherwise receive identical preoperative and postoperative care.

Treatment:

Procedure: Sham Block