Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery
ConditionAcute Achilles Tendon Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWomen's College Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 65
ASA classification: I - III
BMI < 35 kg/m2
Undergoing acute Achilles tendon rupture repair surgery as a day surgery procedure
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Popliteal Nerve Block
Procedure/SurgeryUnder 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 Block
Procedure/SurgeryPatients 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Popliteal nerve (PN) block groupExperimental treatment 1 intervention
Group B: Placebo Nerve BlockSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative Opioid Consumption
Total opioid dose administered to each patient, converted to oral morphine equivalents.
Time frame
The first 24 hours after surgerySecondary outcomes
1
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.
Time frame
The first 24 hours after surgery2
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.
Time frame
At baseline, 6, 24, 48 hours, 7 days and 1-year post-surgery3
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.
Time frame
At baseline, 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery.4
Intraoperative Opioid Consumption
Measurement of opioids administered during surgery, converted into oral morphine equivalents.
Time frame
The first 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov