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Continuous Versus Automated Bolus Infusion in Sciatic Nerve Catheters

NCT02293330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2016-11-23

No results posted yet for this study

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.

Conditions

  • Hallux Valgus
  • Surgery

Interventions

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

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

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Margaretha Breebaart · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293330 on ClinicalTrials.gov