Clinical trial NCT02691442: Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery
Official title: Comparison of the Analgesic Effect of the Local Anesthetics Ropicacaine, Levobupivacaine, and Levobupivacaine + Epinephrin Via Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopy Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Other Peripheral Nerve Disease
Keywords: Peripheral nerve block
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. The investigators want to use the novel method of Quantitative Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold sensation to assess small nerve fiber function. The investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.

Detailed description: This study aims to compare the length of the analgesic effect of different local anesthesic solutions, used in an interscalene nerve block. This will be objectified by measuring the changes in small nerve functioning, using quantative sensory testing. Based on the results of a previous study, the investigators reduce the dose of the administered local anesthetic, expecting a similar length of action using these smaller doses.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia class I or II
* Scheduled for shoulder surgery

Exclusion Criteria:

* Mental retardation
* Allergy for local anesthetics
* NSAID intolerance or contraindicated
* Diabetes mellitus
* Chronic use of pain killers

Primary outcomes:
measure: Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: Need for rescue drugs, as requested by the patient after surgery
timeFrame: 24 hours after intervention
measure: Motor activity block, longitudinally recorded inability to move the blocked limb
timeFrame: 24 hours after intervention
measure: Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing
timeFrame: 24 hours after intervention
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Antwerp
name: Luc Serieus, MD
role: STUDY_CHAIR
References:
citation: Sermeus LA, Schepens T, Hans GH, Morrison SG, Wouters K, Breebaart MB, Smitz CJ, Vercauteren MP. A low dose of three local anesthetic solutions for interscalene blockade tested by thermal quantitative sensory testing: a randomized controlled trial. J Clin Monit Comput. 2019 Apr;33(2):307-316. doi: 10.1007/s10877-018-0150-3. Epub 2018 May 3.