Popliteal Nerve Block for Achilles Tendon Repair Surgery

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06886815
• Lead Sponsor: University of Toronto

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Start: 2025-09
• Primary Completion: 2027-03
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative Opioid Consumption	The first 24 hours after surgery.	Total opioid dose administered to each patient, converted to oral morphine equivalents.

Secondary Outcome Measures

Name	Time	Method
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.
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	Measured at 6, 24, and 48 hours after surgery, as well as 7 days after surgery.	Quality of recovery evaluated using the QoR-15 scale (0 - 150), where 0 represents extremely poor recovery and 150 represents excellent recovery.
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	Until final follow-up (one week postoperative).	The incidence of adverse events possibly attributable to popliteal nerve block, including peripheral nerve injury, hematoma, and infection.
Postoperative Pain Score	Assessed at 0, 6, 12, 18, 24, 36, and 48 hours after surgery, as well as 7 days after surgery.	Measured using the Numeric Rating Scale (0 - 10) where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.
Intraoperative Opioid Consumption	During Achilles tendon repair surgery.	Measurement of opioids administered during surgery, ocnverted 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.

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada