Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02879916
Other study ID # 11/20/162
Secondary ID B300201111454
Status Completed
Phase Phase 4
First received August 11, 2016
Last updated October 26, 2016
Start date October 2011
Est. completion date September 2016

Study information

Verified date October 2016
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial Summary

This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2016
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- ASA class 1 to 3

- Need for shoulder surgery

Exclusion Criteria:

- Mental retardation

- allergy for local anesthetics

- a medical reason as a contra-indication for NSAID use

- Diabetes mellitus

- peripheral neuropathy

- chronic analgetic use

- chronic pain patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Levobupivacaine
Inject 3ml of levobupavacaine into the stellate ganglion area
NaCl 0.9%
Inject 3ml of NaCl 0.9% into the stellate ganglion area

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of analgesia The duration of analgesia assessed with quantitative sensory testing 24 hours No
Secondary Need for rescue analgesia The timing of the need for rescue analgesia as requested by the patient 24 hours No
Secondary Duration of motor block The duration of a motor block 24 hours No
See also
  Status Clinical Trial Phase
Withdrawn NCT04053491 - Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block. N/A
Completed NCT05096377 - Hemi-diaphragmatic Paresis and Erector Spinae Plane Block
Completed NCT03310047 - Intra-individual Reproducibility in Nerve Block Duration Phase 1
Completed NCT04193488 - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery N/A
Completed NCT04201678 - Effectiveness of Erector Spinae Block in Kyphoplasty N/A
Completed NCT02908711 - Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA) Phase 4
Recruiting NCT05100706 - Continuous Adductor Canal Block in Outpatient Total Knee Arthroplasty N/A
Completed NCT04102358 - The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks
Completed NCT03923751 - Survey of Regional Anesthesia Practice in Poland
Completed NCT03038425 - Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients? N/A
Completed NCT05802589 - Comparison of the Efficiency of PENG Block and ESP Block Used for Postoperative Analgesia in Elective Hip Surgery N/A
Recruiting NCT03449680 - The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy N/A
Not yet recruiting NCT03155568 - Safety and Efficacy of Three Local Block Techniques for Diabetic Foot Surgery N/A
Completed NCT03729635 - Pectoral-Intercostal Fascial Plane Block Study N/A
Not yet recruiting NCT06203743 - Evaluation of Caudal Block and Ilioinguinal-ilioohypogastric Nerve Block Efficacy With Perfusion Index (PI) N/A
Completed NCT06201546 - Comparison of Abdominal Plane Blocks in Postoperative Pain Control in Patients Undergoing LSG N/A
Not yet recruiting NCT05734469 - Difference in Occurrence of Rebound Pain in Patients Undergoing Surgery Under Popliteal Block or Ankle Block N/A
Not yet recruiting NCT04301687 - FAB Block vs. Placebo for Hip Arthroplasty Patients N/A
Completed NCT04286035 - Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty Phase 4
Not yet recruiting NCT06316596 - Brain Oxygenation in Newborns Due to Neuroaksial Methods N/A