Acute Achilles Tendon RuptureNCT06886815
Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery
A study testing Popliteal Nerve Block in people with Acute Achilles Tendon Rupture, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Achilles Tendon Rupture
- What is being tested?
- Popliteal Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65
- ASA classification: I - III
- BMI < 35 kg/m2
- Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Didem Bozak, 416-323-6008, didem.bozak@wchospital.ca
Richard Brull, MD,FRCPC
About this study
Official title: 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.
Read the 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
- Being tested
- Popliteal Nerve Block, Sham Block
- Keywords
- Popliteal Nerve Block, Lower Extremity Regional Anesthesia, Achilles Tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal Nerve BlockProcedure or surgery
Also called Popliteal Sciatic 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.
Sham BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Popliteal nerve (PN) block group | Experimental | 30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine Receives: Procedure: Popliteal Nerve Block |
| Placebo Nerve Block | Sham comparator | 1 mL of saline Receives: Procedure: Sham Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Consumption
Total opioid dose administered to each patient, converted to oral morphine equivalents.
Measured: The first 24 hours after surgery
Secondary outcomes (10)
Area Under the Curve for Postoperative Pain
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.
Measured: The first 24 hours after surgery
Quality of Recovery
Quality of recovery evaluated using the QoR-15 scale (0 - 150), where 0 represents extremely poor recovery and 150 represents excellent recovery.
Measured: At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery
Postoperative Pain Score
Measured using the Numeric Rating (NRS) Scale (0 - 10) where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.
Measured: At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.
Intraoperative Opioid Consumption
Measurement of opioids administered during surgery, converted into oral morphine equivalents.
Measured: The first 24 hours after surgery
Time to Analgesic Request
Length of time until the patient's first request for analgesics following surgery.
Measured: The first 24 hours after surgery
Time to Discharge
The length of time each patient stays in Phase I (Postanesthesia Care Unit) and Phase II (Surgical Day Care) after surgery.
Measured: The first 24 hours after surgery
Adverse Events Attributable to Popliteal Block
The incidence of adverse events possibly attributable to popliteal nerve block, including peripheral nerve injury, hematoma, and infection.
Measured: At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery
Adverse Events Attributable to Opioids
The incidence of opioid-related side effects, including sedation, pruritis, nausea/vomiting, and respiratory depression.
Measured: Evaluated at 24 and 48 hours after surgery.
Pain, fatigue, and physical function
Measured using the Achilles tendon Total Rupture Score (ATRS)
Measured: Prior to surgery and 1-year post-surgery
Neuropathic pain
Measured using the English version of the Douleur Neuropathique 4 (DN4) Questionnaire
Measured: At 1 week and 1-year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start17 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a prospective, double-blinded, randomized controlled superiority trial with two parallel arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886815
- Sponsor's protocol ID
- 2025-0039-B
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06886815
- Acronym / sponsor ID
- 2025-0039-B
- Conditions
- Acute Achilles Tendon Rupture
- Keywords
- Popliteal Nerve Block, Lower Extremity Regional Anesthesia, Achilles Tendon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a prospective, double-blinded, randomized controlled superiority trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Popliteal nerve (PN) block group | Experimental | Procedure: Popliteal Nerve Block30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine |
| Placebo Nerve Block | Sham comparator | Procedure: Sham Block1 mL of saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 65
- ASA classification: I - III
- BMI < 35 kg/m2
- Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Popliteal Nerve BlockAlso: Popliteal Sciatic Nerve BlockUnder 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. | Procedure or surgery | Popliteal nerve (PN) block group |
| Sham BlockPatients 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. | Procedure or surgery | Placebo Nerve Block |
Primary outcome
Cumulative Opioid Consumption
Time frame: The first 24 hours after surgery
Total opioid dose administered to each patient, converted to oral morphine equivalents.
10 secondary outcomes
Area Under the Curve for Postoperative Pain
Time frame: The first 24 hours after surgery
Quality of Recovery
Time frame: 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.
Intraoperative Opioid Consumption
Time frame: The first 24 hours after surgery
Time to Analgesic Request
Time frame: The first 24 hours after surgery
Time to Discharge
Time frame: 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
Adverse Events Attributable to Opioids
Time frame: Evaluated at 24 and 48 hours after surgery.
Pain, fatigue, and physical function
Time frame: Prior to surgery and 1-year post-surgery
Neuropathic pain
Time frame: At 1 week and 1-year post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- BackgroundBrenna 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.
- Individual participant dataSharing planned: No
Related trials for Acute Achilles Tendon Rupture
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Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Not yet recruiting
Achilles Tendon Rupture - Intervention With Electrical Stimulation
Achilles Tendon Ruptures, Immobilization
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Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Brull, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Popliteal Nerve Block in people with Acute Achilles Tendon Rupture, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didem Bozak (416-323-6008, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Opioid Consumption (time frame: The first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.