- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886815
Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery
April 21, 2026 updated by: Women's College Hospital
The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Didem Bozak
- Phone Number: 416-323-6008
- Email: didem.bozak@wchospital.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1B2
- Recruiting
- Women's College Hospital
-
Principal Investigator:
- Richard Brull, MD,FRCPC
-
Contact:
- Didem Bozak
- Phone Number: 416-323-6008
- Email: didem.bozak@wchospital.ca
-
Sub-Investigator:
- Connor TA Brenna, MD
-
Sub-Investigator:
- Seung C Kim, MD,FFPMRCA
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Sub-Investigator:
- Faraj W Abdallah, MD,FRCPC
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Sub-Investigator:
- Sam Park, MD,MASc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Popliteal nerve (PN) block group
30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine
|
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.
Other Names:
|
|
Sham Comparator: Placebo Nerve Block
1 mL of saline
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Opioid Consumption
Time Frame: The first 24 hours after surgery
|
Total opioid dose administered to each patient, converted to oral morphine equivalents.
|
The first 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events Attributable to Opioids
Time Frame: Evaluated at 24 and 48 hours after surgery.
|
The incidence of opioid-related side effects, including sedation, pruritis, nausea/vomiting, and respiratory depression.
|
Evaluated at 24 and 48 hours after surgery.
|
|
Area Under the Curve for Postoperative Pain
Time Frame: 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.
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The first 24 hours after surgery
|
|
Quality of Recovery
Time Frame: At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery
|
Quality of recovery evaluated using the QoR-15 scale (0 - 150), where 0 represents extremely poor recovery and 150 represents excellent recovery.
|
At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery
|
|
Postoperative Pain Score
Time Frame: At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.
|
Measured using the Numeric Rating (NRS) Scale (0 - 10) where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.
|
At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.
|
|
Intraoperative Opioid Consumption
Time Frame: The first 24 hours after surgery
|
Measurement of opioids administered during surgery, converted into oral morphine equivalents.
|
The first 24 hours after surgery
|
|
Time to Analgesic Request
Time Frame: The first 24 hours after surgery
|
Length of time until the patient's first request for analgesics following surgery.
|
The first 24 hours after surgery
|
|
Time to Discharge
Time Frame: 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.
|
The first 24 hours after surgery
|
|
Adverse Events Attributable to Popliteal Block
Time Frame: At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery
|
The incidence of adverse events possibly attributable to popliteal nerve block, including peripheral nerve injury, hematoma, and infection.
|
At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery
|
|
Pain, fatigue, and physical function
Time Frame: Prior to surgery and 1-year post-surgery
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Measured using the Achilles tendon Total Rupture Score (ATRS)
|
Prior to surgery and 1-year post-surgery
|
|
Neuropathic pain
Time Frame: At 1 week and 1-year post-surgery
|
Measured using the English version of the Douleur Neuropathique 4 (DN4) Questionnaire
|
At 1 week and 1-year post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Brull, MD, FRCPC, University Health Network, Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
March 14, 2025
First Submitted That Met QC Criteria
March 14, 2025
First Posted (Actual)
March 20, 2025
Study Record Updates
Last Update Posted (Actual)
April 23, 2026
Last Update Submitted That Met QC Criteria
April 21, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-0039-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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