We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 20, 2022
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : December 30, 2022
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Eric Albrecht, PD Dr +41 79 556 63 41 eric.albrecht@chuv.ch

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Eric Albrecht, PD Dr Centre Hospitalier Universitaire Vaudois
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations