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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03411343
Date of registration: 05/01/2018
Prospective Registration: Yes
Primary sponsor: University of Chile
Public title: Interscalene Block Versus Costoclavicular Block for Shoulder Surgery
Scientific title: A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
Date of first enrolment: April 9, 2018
Target sample size: 44
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03411343
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Care Provider, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Chile
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients undergoing arthroscopic shoulder surgery

- American Society of Anesthesiologists classification 1-3

- Body mass index between 20 and 35

Exclusion Criteria:

- Adults who are unable to give their own consent

- Pre-existing neuropathy

- Coagulopathy

- Obstructive or restrictive pulmonary disease

- Renal failure

- Hepatic failure

- Allergy to local anesthetics

- Pregnancy

- Prior surgery in the corresponding side of the neck or infraclavicular fossa

- Chronic pain syndromes requiring opioid intake at home



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Diaphragmatic Paralysis
Pain, Postoperative
Shoulder Pain
Surgical Procedure, Unspecified
Intervention(s)
Procedure: Interscalene Block
Procedure: Costoclavicular Infraclavicular Block
Primary Outcome(s)
Static pain at 30 minutes after arrival in the PACU [Time Frame: 30 minutes]
Secondary Outcome(s)
Postoperative static pain at 3 hours [Time Frame: 3 hours]
Sensory and Motor block score [Time Frame: 30 minutes post injection]
Surgical duration [Time Frame: Intraoperative period]
Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block [Time Frame: 30 minutes post injection]
Block- and opioid-related side effects [Time Frame: 1 week]
Postoperative static pain at 24 hours [Time Frame: 24 hours]
Postoperative opioid consumption [Time Frame: 24 hours after surgery]
Postoperative static pain at 6 hours [Time Frame: 6 hours]
Incidence of HDP at 30 minutes after arrival to PACU [Time Frame: 30 minutes after arrival to the PACU]
Patient satisfaction [Time Frame: 24 hours after surgery]
Procedural pain during blocks [Time Frame: 1 hour before surgery]
Intraoperative opioid requirements [Time Frame: Intraoperative period]
Incidence of complete block [Time Frame: 30 minutes post injection]
Onset time [Time Frame: 1 hour before surgery]
Block performance time [Time Frame: 1 hour before surgery]
Postoperative static pain at 2 hours [Time Frame: 2 hours]
Postoperative static pain at 12 hours [Time Frame: 12 hours]
Static pain at 60 minutes after arrival in the PACU [Time Frame: 60 minutes]
Secondary ID(s)
889/17
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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