Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery

NCT ID: NCT06886815

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-03-31

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.

Conditions

Acute Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Popliteal nerve (PN) block group

30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine

Group Type: EXPERIMENTAL

Popliteal Nerve Block

Intervention Type: PROCEDURE

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.

Placebo Nerve Block

1 mL of saline

Group Type: SHAM_COMPARATOR

Sham Block

Intervention Type: PROCEDURE

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.

Interventions

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 by patients with knowledge of the technique.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Popliteal Sciatic Nerve Block

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brull, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Women's College Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Didem Bozak

Role: CONTACT

didem.bozak@wchospital.ca

416-323-6008

Facility Contacts

Didem Bozak

Role: primary

didem.bozak@wchospital.ca

416-323-6008

References

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.

Reference Type: BACKGROUND

Other Identifiers

2025-0039-B

Identifier Type: -

Identifier Source: org_study_id