NCT02271867

Brief Summary

Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

October 13, 2014

Last Update Submit

October 20, 2014

Conditions

Anesthetics, LocalNerve Block

Outcome Measures

Primary Outcomes (1)

  • Presence of sensory block

    24 hours after intervention

Secondary Outcomes (4)

  • Degree of sensory stimulus detection threshold variation from baseline values

    24 hours after intervention

  • Block duration

    24 hours after intervention

  • Use of rescue medication

    24 hours after intervention

  • Presence of motor block

    24 hours after intervention

Study Arms (3)

Levobupivacaine 0,5%

ACTIVE COMPARATOR

Levobupivacaine 0,5% 15 ml once

Procedure: Interscalene block

Levobupivacaine 0,5% with epinephrine

ACTIVE COMPARATOR

Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once

Procedure: Interscalene block

Ropivacaine 0,75%

ACTIVE COMPARATOR

Ropivacaine 0,75% 15 ml once

Procedure: Interscalene block

Interventions

Interscalene blockPROCEDURE

An ultrasound guided ISB was performed with injection aimed to block the C5-root

Levobupivacaine 0,5%Levobupivacaine 0,5% with epinephrineRopivacaine 0,75%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible

You may not qualify if:

  • contraindications for ISB
  • diabetes mellitus
  • peripheral neuropathy
  • patients receiving chronic analgesic therapy
  • contraindications for NSAID
  • patients with an initial QST with abnormal values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

  • Sermeus LA, Hans GH, Schepens T, Bosserez NM, Breebaart MB, Smitz CJ, Vercauteren MP. Thermal quantitative sensory testing to assess the sensory effects of three local anesthetic solutions in a randomized trial of interscalene blockade for shoulder surgery. Can J Anaesth. 2016 Jan;63(1):46-55. doi: 10.1007/s12630-015-0505-x. Epub 2015 Oct 16.

    PMID: 26475166DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thermal Quantitative Sensory Testing as a method to semi-quantitatively assess the neurosensory effects of 3 local anesthetic solutions in an interscalene block

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 22, 2014

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations

BE(1)