Popliteal Nerve Block for Achilles Tendon Repair

Overseen By Connor T.A. Brenna, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Oxycodone, Local anesthetics

Disqualifiers: Neurological deficits, Chronic pain, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Surgery has traditionally been the mainstay of treatment for patients who experience acute Achilles tendon rupture, and anesthesia for this operation often includes a popliteal nerve block. However, the evidence basis for this practice is uncertain, and popliteal nerve block has associated risks such as peripheral nerve injury. This research study will evaluate the effects of popliteal nerve block on postoperative pain, recovery, and quality of life after Achilles tendon repair surgery, in order to better inform patient and provider decisions to receive or perform popliteal nerve block for this operation.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking over 30 mg of oxycodone or equivalent per day, you may not be eligible to participate.

What data supports the effectiveness of the treatment Popliteal Nerve Block for Achilles Tendon Repair?

Research shows that using a popliteal nerve block, especially when guided by ultrasound, can effectively reduce pain after Achilles tendon repair. It also decreases the need for pain medication like fentanyl and delays the time before patients need their first dose of pain relief after surgery. ^{1 2 3 4 5}

Is the popliteal nerve block generally safe for humans?

Popliteal nerve blocks are commonly used in foot and ankle surgeries and are generally considered safe, but like any medical procedure, they can have complications. Some potential issues include nerve damage or other rare complications, so it's important to discuss these risks with your healthcare provider. ^{2 4 5 6 7}

How is the popliteal nerve block treatment different for Achilles tendon repair?

The popliteal nerve block is unique because it provides targeted pain relief by numbing the sciatic nerve in the popliteal fossa (the area behind the knee), which can reduce the need for general anesthesia and opioids. This approach offers effective and prolonged pain relief after Achilles tendon repair, allowing for a quicker recovery with fewer side effects compared to traditional pain management methods. ^{1 2 5 8 9}

Research Team

Richard Brull, MD FRCPC

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for patients undergoing Achilles tendon repair surgery. Participants should be suitable for caudal epidural block therapy or regional anesthesia. Those with a ruptured corpus cavernosum are excluded, ensuring the focus remains on individuals specifically dealing with Achilles tendon issues.

Inclusion Criteria

BMI < 35 kg/m2

My health is good to moderately impaired.

I am having day surgery for an Achilles tendon repair.

Exclusion Criteria

History of use of over 30 mg oxycodone or equivalent per day

History of significant psychiatric conditions that may affect patient assessment

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Patients receive preoperative care including non-invasive monitoring and intravenous midazolam for anxiolysis

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Patients undergo Achilles tendon repair surgery with either a popliteal nerve block or sham block, followed by immediate postoperative care

1 day

1 visit (in-person)

Acute Postoperative Monitoring

Monitoring of pain, recovery, and adverse events in the first 24 hours after surgery

24 hours

Subacute Postoperative Monitoring

Continued monitoring of recovery and adverse events up to one week after surgery

1 week

1 visit (in-person), study diary entries

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Popliteal Nerve Block

Trial Overview The study tests the effectiveness of popliteal nerve blocks in managing postoperative pain and aiding recovery after Achilles tendon repair surgery. It compares real popliteal nerve blocks against sham blocks (placebos) to assess their impact on patient outcomes.

Participant Groups

Group I: Popliteal Nerve Block Group Experimental Treatment 1 Intervention

Patients will be randomly assigned to this, or a comparator, group. In accordance with routine pre-block management, non-invasive blood pressure, electrocardiogram, and pulse oximeter will be attached to the patient. A 20G intravenous access will be secured in the upper extremity to begin administering an intravenous infusion of Lactated Ringer's solution. Prior to block performance, all patients will receive intravenous midazolam 1 - 4 mg IV for anxiolysis. In a designated block room, a regional anesthesiologist or anesthesia fellow with experience performing popliteal nerve blocks will sterilize the popliteus of the surgical knee with 2% chlorhexidine swabs, infiltrate it with 2 mL 2% lidocaine, and visualize the underlying anatomy using ultrasound. They will then perform a popliteal nerve block for patients in this group. Patients in both groups will otherwise receive identical preoperative and postoperative care.

Group II: Control Group Placebo Group 1 Intervention

Patients will be randomly assigned to this, or an intervention, group. In accordance with routine pre-block management, non-invasive blood pressure, electrocardiogram, and pulse oximeter will be attached to the patient. A 20G intravenous access will be secured in the upper extremity to begin administering an intravenous infusion of Lactated Ringer's solution. Prior to block performance, all patients will receive intravenous midazolam 1 - 4 mg IV for anxiolysis. In a designated block room, a regional anesthesiologist or anesthesia fellow with experience performing popliteal nerve blocks will sterilize the popliteus of the surgical knee with 2% chlorhexidine swabs, infiltrate it with 2 mL 2% lidocaine, and visualize the underlying anatomy using ultrasound. They will then perform a sham block for patients in this group. Patients in both groups will otherwise receive identical preoperative and postoperative care.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Ultrasound-guided sciatic nerve block in the popliteal fossa for the postoperative pain control after Achilles' tendon repair]. [2012]

2. France pubmed.ncbi.nlm.nih.gov

Techniques and complications of popliteal nerve blocks. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Combined Popliteal Catheter With Single-Injection vs Continuous-Infusion Saphenous Nerve Block for Foot and Ankle Surgery. [2019]

4. France pubmed.ncbi.nlm.nih.gov

Lateral popliteal block in foot and ankle surgery: Comparing ultrasound guidance to nerve stimulation. A prospective randomized trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Combined popliteal and saphenous nerve blocks at the knee: an underused alternative to general or spinal anesthesia for foot and ankle surgery. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Local Ketorolac Injection vs Popliteal Sciatic Nerve Blockade as an Adjuvant to a Spinal Block in Hindfoot Arthrodesis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Tibial nerve block with anesthetics resulting in achilles tendon avulsion. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Techniques of popliteal nerve regional anesthesia. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Popliteal sciatic nerve blocks after foot and ankle surgery: an adjunct to postoperative analgesia. [2019]