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CompletedNCT03683342Updated Aug 3, 2023

Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery

An interventional study of Ankle Block and Sciatic nerve block in Pain, Postoperative, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Pain after forefoot surgery can be important and regional anesthesia plays a crucial role in post-operative pain control. Several techniques can be used to achieve surgical anesthesia as well as postoperative analgesia. Of those techniques the ankle block and sciatic nerve block at the popliteal fossa are the most common. The primary goal of this study is thus to compare the analgesic duration of these two types of blocks for patients undergoing forefoot surgery.

Read the detailed description

Patients scheduled for unilateral forefoot surgery, aged over 18 years old and ASA status I-III without any contra-indications for regional anesthesia will be enrolled.

After a standard randomisation, patients will be allocated in either of two groups : ankle block or sciatic nerve block at the popliteal fossa. In both groups the patients will have a multimodal analgesic regimen followed by a patient-controlled-analgesia (PCA) of morphine.

The primary endpoint is the analgesic duration, defined by the time between the end of the block procedure and the first IV request of morphine from a PCA.

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Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are going to undergo a unilateral forefoot surgery ;
  • ASA I-III ;
  • Aged 18 years or more;
  • Weighing at least 45 kg

Exclusion criteria

Exclusion Criteria:

  • Patient refusal and/or language/cognitive barrier
  • Pregnancy
  • Contra-indication for regional anesthesia
  • Opiate or alcohol dependency
  • Concomitant oncological disease with chemotherapy
  • Patients suffering from neuropathic pain
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Ankle Block

    Ankle block will be performed under ultrasound guidance.

    Procedure: Ankle Block

  • Active comparator
    Popliteal sciatic nerve block (PSNB)

    PSNB will be performed under ultrasound guidance, along with a saphenous nerve block at the ankle

    Procedure: Sciatic nerve block

Interventions

  • ProcedureAnkle Block

    Ankle block will be performed prior to surgery under ultrasound guidance

  • ProcedureSciatic nerve block

    Sciatic nerve block will be performed prior to surgery under ultrasound guidance

06

What researchers measure

Primary outcomes

  1. Duration of analgesia

    Time elapsed between block procedure and first iv request of morphine from PCA

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Total opioid consumption at 24h postoperatively

    Total consumption of morphine from PCA at 24 postoperative hours

    Time frame: 24 hours after surgery

  2. Pain score at rest at 4 postoperative hours

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 4 hours after surgery

  3. Pain score on movement at 4 postoperative hours

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 4 hours after surgery

  4. Pain score at rest at 12 postoperative hours

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 12 hours after surgery

  5. Pain score on movement at 12 postoperative hours

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 12 hours after surgery

  6. Pain score at rest at 24 postoperative hours

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 24 hours after surgery

  7. Pain score on movement at 24 postoperative hours

    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 24 hours after surgery

  8. Block success rate

    Success of block assessed by pinprick test

    Time frame: 45 minutes after block procedure

  9. Global patient satisfaction 48h after surgery

    Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)

    Time frame: 48 hours after surgery

  10. Complications after block

    Report of any intravascular injection or any sensory/motor anomalies

    Time frame: 48 hours after surgery

  11. Rate of neuropathic pain

    Rate of patients describing neuropathic pain 4-6 weeks postoperatively

    Time frame: 4-6 weeks postoperatively

  12. Rate of paresthesia

    Rate of patients complaining of paresthesia

    Time frame: Up to 24 hours after block procedure

  13. Block procedure time

    Time from first ultrasound image to needle withdrawal

    Time frame: Up to 10 minutes after ultrasound scanning

07

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois and University of Lausanne
    Lausanne, Vaud 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03683342
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Responsible party
Eric Albrecht (Program director of regional anesthesia, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Sep 25, 2018
Start date
Sep 20, 2018
Primary completion
Nov 1, 2022
Completion
Dec 30, 2022
Last update
Aug 3, 2023

Study contacts

Eric Albrecht, PD Dr
principal investigator · Centre Hospitalier Universitaire Vaudois

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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