Continuous Versus Automated Bolus Infusion in Sciatic Nerve Catheters

NCT02293330 | Completed Phase 4

• 1 other identifier: 14/38/393
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus; Surgery

Keywords

continuous versus intermittent bolus sciatic nerve block

Outcome Measures

Primary Outcomes (1)

• local anesthetic dose in 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)

  48 hours

Secondary Outcomes (5)

• pains scores

  48 hours

• motor block (possibility of tow movement ( yes/no)

  48 hours

• sensory block loss of cold sensation (yes/no)

  48 hours

• numbness (sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing)

  48 hours

• patient satisfaction 9satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied)

  48 hours

Other Outcomes (1)

• first sensation after stopping the pomp

  two days after discharge

Study Arms (2)

C group

EXPERIMENTAL

continuous infusion of levobupivacaine

Drug: continuous infusion of levobupivacaine

B group

EXPERIMENTAL

Intermittent bolus infusion of levobupivacaine

Drug: Intermittent bolus infusion of levobupivacaine

Interventions

continuous infusion of levobupivacaine DRUG

continuous infusion of levobupivacaine 0,125% at 5 ml/h , bolus dose 6 ml, lock out 30 minutes 4 hours limit: 60 ml/h

Also known as: chirocaine

C group

Intermittent bolus infusion of levobupivacaine DRUG

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

Also known as: chirocaine

B group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Hallux Valgus

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Margaretha Breebaart

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

BE (1)