Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery

NCT06886815 | Recruiting

• 1 other identifier: 2025-0039-B
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Achilles Tendon Rupture

Keywords

Popliteal Nerve Block; Lower Extremity Regional Anesthesia; Achilles Tendon

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption

  Total opioid dose administered to each patient, converted to oral morphine equivalents.

  The first 24 hours after surgery

Secondary Outcomes (10)

• Area Under the Curve for Postoperative Pain

  The first 24 hours after surgery

• Quality of Recovery

  At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery

• Postoperative Pain Score

  At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.

• Intraoperative Opioid Consumption

  The first 24 hours after surgery

• Time to Analgesic Request

  The first 24 hours after surgery

Study Arms (2)

Popliteal nerve (PN) block group

EXPERIMENTAL

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

Procedure: Popliteal Nerve Block

Placebo Nerve Block

SHAM COMPARATOR

1 mL of saline

Procedure: Sham Block

Interventions

Popliteal Nerve Block 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.

Also known as: Popliteal Sciatic Nerve Block

Popliteal nerve (PN) block group

Sham Block 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.

Placebo Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65
• ASA classification: I - III
• BMI \< 35 kg/m2
• Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

Study Officials

• Richard Brull, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

416-323-6008; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a prospective, double-blinded, randomized controlled superiority trial with two parallel arms.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)