NCT Number: NCT06886815
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5S 1B2, Canada
Location status: Recruiting
Connor TA Brenna, MD
SUB_INVESTIGATOR
Didem Bozak
CONTACT
Faraj W Abdallah, MD,FRCPC
SUB_INVESTIGATOR
Richard Brull, MD,FRCPC
PRINCIPAL_INVESTIGATOR
Sam Park, MD,MASc
SUB_INVESTIGATOR
Seung C Kim, MD,FFPMRCA
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Popliteal Sciatic Nerve 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.
Time frame: The first 24 hours after surgery
Total opioid dose administered to each patient, converted to oral morphine equivalents.
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.
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.
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.
Time frame: The first 24 hours after surgery
Measurement of opioids administered during surgery, converted into oral morphine equivalents.
Time frame: The first 24 hours after surgery
Length of time until the patient's first request for analgesics following surgery.
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.
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.
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.
Time frame: Prior to surgery and 1-year post-surgery
Measured using the Achilles tendon Total Rupture Score (ATRS)
Time frame: At 1 week and 1-year post-surgery
Measured using the English version of the Douleur Neuropathique 4 (DN4) Questionnaire
Contact information is provided by the study sponsor or research team.
Women's College Hospital
Other
The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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