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Continuous Versus Automated Bolus Infusion in Sciatic Nerve Catheters

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ClinicalTrials.gov Identifier: NCT02293330
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Dr M. B. Breebaart, University Hospital, Antwerp

Brief Summary:
This study is developed to determine if the local anaesthetic dose can be reduced by the use of intermittent bolus technique compared to continuous infusion when the nerve catheter is placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is necessary the first postoperative 48 hours after surgery for adequate postoperative analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during the nerve block and afterwards.

Condition or disease Intervention/treatment Phase
Hallux Valgus Surgery Drug: continuous infusion of levobupivacaine Drug: Intermittent bolus infusion of levobupivacaine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Official Title: Continuous Infusion Versus Automated Intermittent Bolus of Levobupivacaine 0,1% in Ultrasound Guided Subparaneural Sciatic Nerve Catheters. A Prospective Double Blind Randomised Study.
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C group
continuous infusion of levobupivacaine
Drug: continuous infusion of levobupivacaine
continuous infusion of levobupivacaine 0,125% at 5 ml/h , bolus dose 6 ml, lock out 30 minutes 4 hours limit: 60 ml/h
Other Name: chirocaine

Experimental: B group
Intermittent bolus infusion of levobupivacaine
Drug: Intermittent bolus infusion of levobupivacaine
Intermittent bolus of levobupivacaine 0,125%: 0.1 ml /h and 9,8 ml bolus every two hours. Optional patient controlled bolus dose 6 ml, lock out 30 minutes, 4 hours limit: 60 ml/h
Other Name: chirocaine




Primary Outcome Measures :
  1. local anesthetic dose in 48 hours [ Time Frame: 48 hours ]
    the total amount of local anesthetic dose (mg) in total administered by the pump connected to the sciatic nerve catheter from start of the pump until stop ( 48 hours after start)


Secondary Outcome Measures :
  1. pains scores [ Time Frame: 48 hours ]
    pain scores on a numeric rating scale (0-10) will b scored on regular intervals ( every 4 hours)

  2. motor block (possibility of tow movement ( yes/no) [ Time Frame: 48 hours ]
    possibility of tow movement ( yes/no) 6,12,24,30,36 and 48 hours after starting the pump)

  3. sensory block loss of cold sensation (yes/no) [ Time Frame: 48 hours ]
    loss of cold sensation ( yes/no) in peroneal an tibial dermatome , measured at 6,12,24,30,36 hours after starting the pump

  4. numbness (sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing) [ Time Frame: 48 hours ]
    sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing) measured at 6,12,24,30,36,48 hours after starting the pump

  5. patient satisfaction 9satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied) [ Time Frame: 48 hours ]
    satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied)


Other Outcome Measures:
  1. first sensation after stopping the pomp [ Time Frame: two days after discharge ]
    the patient is asked to note the time point (day, hour) at which sensation and /or motor function returned. A nurse will call two days after discharge to ask.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • scheduled for for surgery for hallux valgus pathology with general anesthesia and a popliteal nerve catheter (=sciatic nerve block)

Exclusion Criteria:

  • neuromuscular disease,
  • chronic pain,
  • peripheral neuropathy in lower limb,
  • contraindication for popliteal nerve block,
  • unable to use pca (patient controlled analgesia),
  • patient refusal

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): NCT02293330


Locations
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Belgium
University Hospital Antwerp
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Margaretha Breebaart University Hospital, Antwerp

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Responsible Party: Dr M. B. Breebaart, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02293330     History of Changes
Other Study ID Numbers: 14/38/393
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Dr M. B. Breebaart, University Hospital, Antwerp:
continuous versus intermittent bolus sciatic nerve block

Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents