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Clinical Trials/2022-501312-34-01
2022-501312-34-01CompletedPhase 4

The Intertransverse Process Block - Single or Multiple Injection? A randomised, procedure related, blinded crossover trial in healthy volunteers

Zealand University Hospital1 site in 1 country12 target enrollmentStarted: January 24, 2023Last updated:
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Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The main overall objective is to determine the efficacy of the intertransverse process block.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age ≥ 18 years at the date of inclusion
  • •American Associations of Anaesthesiologist (ASA) class I-II
  • •Have received thorough information, orally and in written form, and signed the “Informed Consent” form on participation in the study.
  • •Weight > 52,5 kilograms (chosen due to the international maximal single dose of Ropivacaine (3mg/kg)

Exclusion Criteria

  • •Substantial co-morbidity: American Associations of Anaesthesiologist (ASA) class > II
  • •Daily intake of analgesics (investigators decision)
  • •Alcohol and/or drug overuse (investigators decision)
  • •Previous thoracic trauma or thoracic surgery
  • •Previous/current piercing of the nipple of any kind on blockade side
  • •Tattoos on the thorax (according to the investigators decision)
  • •Any systemic muscular or neuromuscular disease
  • •Any use of vasodilatory substance (investigators decision)
  • •Local infection at the site of injection or systemic infection
  • •Difficult sonoanatomical visualisation of the target area (SCTL, ITTC etc.) necessary for the block execution
  • •Severe hypovolemia
  • •Inability to speak and understand Danish
  • •Inability to cooperate
  • •Allergy to study drugs

Outcomes

Primary Outcomes

The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes

The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes

Secondary Outcomes

  • “Sensory mapping”: the extent of cutaneous spread of the sensory block (area in cm2)
  • To evaluate thermography in a clinical setup (the temperature differences between non-blockade side and blockade side)
  • To evaluate changes in non-invasive blood pressure
  • To evaluate block application satisfaction in numeric rating scale pain scores

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Jens Børglum

Scientific

Zealand University Hospital

Study Sites (1)

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ITP block: single or multiple injection? | Clinical Trial