The Effects of Popliteal Nerve Block on Pain and Nerve-Related Symptoms After Acute Achilles Tendon Rupture Repair Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Women's College Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Cumulative Opioid Consumption
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Popliteal nerve (PN) block group
30 mL of 0.5% ropivacaine with 2.5 µg/ml of epinephrine
Intervention: Popliteal Nerve Block (Procedure)
Placebo Nerve Block
1 mL of saline
Intervention: Sham Block (Procedure)
Outcomes
Primary Outcomes
Cumulative Opioid Consumption
Time Frame: The first 24 hours after surgery
Total opioid dose administered to each patient, converted to oral morphine equivalents.
Secondary Outcomes
- Adverse Events Attributable to Opioids(Evaluated at 24 and 48 hours after surgery.)
- Time to Analgesic Request(The first 24 hours after surgery)
- Adverse Events Attributable to Popliteal Block(At 0, 6, 12, 18, 24, 36, 48 hours, 7 days and 1-year post-surgery)
- Adverse Events Attributable to Opioids(Evaluated at 24 and 48 hours after surgery.)
- Pain, fatigue, and physical function(Prior to surgery and 1-year post-surgery)
- Neuropathic pain(At 1 week and 1-year post-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 Discharge(The first 24 hours after surgery)
- Area Under the Curve for Postoperative Pain(The first 24 hours after surgery)