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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683342
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Ankle Block Procedure: Sciatic nerve block Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Analgesic Duration of Popliteal Block Versus Ankle Block in Patients Undergoing Forefoot Surgery
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : May 15, 2022

Arm Intervention/treatment
Active Comparator: Ankle Block
Ankle block will be performed under ultrasound guidance.
Procedure: Ankle Block
Ankle block will be performed prior to surgery under ultrasound guidance

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




Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 24 hours after surgery ]
    Time elapsed between block procedure and first iv request of morphine from PCA


Secondary Outcome Measures :
  1. Total opioid consumption at 24h postoperatively [ Time Frame: 24 hours after surgery ]
    Total consumption of morphine from PCA at 24 postoperative hours

  2. Pain score at rest at 4 postoperative hours [ Time Frame: 4 hours after surgery ]
    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  3. Pain score on movement at 4 postoperative hours [ Time Frame: 4 hours after surgery ]
    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  4. Pain score at rest at 12 postoperative hours [ Time Frame: 12 hours after surgery ]
    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  5. Pain score on movement at 12 postoperative hours [ Time Frame: 12 hours after surgery ]
    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  6. Pain score at rest at 24 postoperative hours [ Time Frame: 24 hours after surgery ]
    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  7. Pain score on movement at 24 postoperative hours [ Time Frame: 24 hours after surgery ]
    Pain score (visual analog scale, 0 = minimum; 10 = maximum)

  8. Block success rate [ Time Frame: 45 minutes after block procedure ]
    Success of block assessed by pinprick test

  9. Global patient satisfaction 48h after surgery [ Time Frame: 48 hours after surgery ]
    Patient satisfaction score (visual analog scale, 0 = minimum; 10 = maximum)

  10. Complications after block [ Time Frame: 48 hours after surgery ]
    Report of any intravascular injection or any sensory/motor anomalies

  11. Rate of neuropathic pain [ Time Frame: 4-6 weeks postoperatively ]
    Rate of patients describing neuropathic pain 4-6 weeks postoperatively

  12. Rate of paresthesia [ Time Frame: Up to 24 hours after block procedure ]
    Rate of patients complaining of paresthesia

  13. Block procedure time [ Time Frame: Up to 10 minutes after ultrasound scanning ]
    Time from first ultrasound image to needle withdrawal



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683342


Contacts
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Contact: Eric Albrecht, PD Dr +41 79 556 63 41 eric.albrecht@chuv.ch

Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois and University of Lausanne Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Eric Albrecht, PD Dr    +41795566341    eric.albrecht@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Eric Albrecht, PD Dr Centre Hospitalier Universitaire Vaudois
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Responsible Party: Eric Albrecht, Program director of regional anesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03683342    
Other Study ID Numbers: CER-VD 2018-01090
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations