Interscalene Block Versus Costoclavicular Block for Shoulder Surgery
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|ClinicalTrials.gov Identifier: NCT03411343|
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : July 10, 2018
Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery.
The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Shoulder Pain Surgical Procedure, Unspecified Diaphragmatic Paralysis||Procedure: Interscalene Block Procedure: Costoclavicular Infraclavicular Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery|
|Actual Study Start Date :||April 9, 2018|
|Actual Primary Completion Date :||July 6, 2018|
|Actual Study Completion Date :||July 6, 2018|
Active Comparator: Interscalene Block
Patients randomized to receive an intesrcalene block.
Procedure: Interscalene Block
Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.
Experimental: Costoclavicular Infraclavicular Block
Patients randomized to receive a costoclavicular infraclavicular block.
Procedure: Costoclavicular Infraclavicular Block
Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.
- Static pain at 30 minutes after arrival in the PACU [ Time Frame: 30 minutes ]Evaluated with a NRS from 0 to 10
- Static pain at 60 minutes after arrival in the PACU [ Time Frame: 60 minutes ]Evaluated with a NRS from 0 to 10
- Postoperative static pain at 2 hours [ Time Frame: 2 hours ]Evaluated with a NRS from 0 to 10
- Postoperative static pain at 3 hours [ Time Frame: 3 hours ]Evaluated with a NRS from 0 to 10
- Postoperative static pain at 6 hours [ Time Frame: 6 hours ]Evaluated with a NRS from 0 to 10
- Postoperative static pain at 12 hours [ Time Frame: 12 hours ]Evaluated with a NRS from 0 to 10
- Postoperative static pain at 24 hours [ Time Frame: 24 hours ]Evaluated with a NRS from 0 to 10
- Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block [ Time Frame: 30 minutes post injection ]Ultrasound diagnosed HDP
- Incidence of HDP at 30 minutes after arrival to PACU [ Time Frame: 30 minutes after arrival to the PACU ]Ultrasound diagnosed HDP
- Block performance time [ Time Frame: 1 hour before surgery ]Time from skin disinfection until the end of local anesthetic injection
- Sensory and Motor block score [ Time Frame: 30 minutes post injection ]Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score
- Incidence of complete block [ Time Frame: 30 minutes post injection ]Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection
- Procedural pain during blocks [ Time Frame: 1 hour before surgery ]Evaluated with a NRS from 0 to 10
- Onset time [ Time Frame: 1 hour before surgery ]Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points
- Intraoperative opioid requirements [ Time Frame: Intraoperative period ]Total amount of fentanyl required during general anesthesia
- Surgical duration [ Time Frame: Intraoperative period ]Time between skin incision and closure
- Postoperative opioid consumption [ Time Frame: 24 hours after surgery ]Total amount of morphine required during the first 24 hours after surgery
- Patient satisfaction [ Time Frame: 24 hours after surgery ]Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
- Block- and opioid-related side effects [ Time Frame: 1 week ]Incidence of side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411343
|Hospital Clínico Universidad de Chile|
|Santiago, Metropolitana, Chile, 8380456|