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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
44
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.
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.
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
Static pain at 30 minutes after arrival in the PACU
Evaluated with a NRS from 0 to 10
Time frame: 30 minutes
Static pain at 60 minutes after arrival in the PACU
Evaluated with a NRS from 0 to 10
Time frame: 60 minutes
Postoperative static pain at 2 hours
Evaluated with a NRS from 0 to 10
Time frame: 2 hours
Postoperative static pain at 3 hours
Evaluated with a NRS from 0 to 10
Time frame: 3 hours
Postoperative static pain at 6 hours
Evaluated with a NRS from 0 to 10
Time frame: 6 hours
Postoperative static pain at 12 hours
Evaluated with a NRS from 0 to 10
Time frame: 12 hours
Postoperative static pain at 24 hours
Evaluated with a NRS from 0 to 10
Time frame: 24 hours
Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block
Ultrasound diagnosed HDP
Time frame: 30 minutes post injection
Incidence of HDP at 30 minutes after arrival to PACU
Ultrasound diagnosed HDP
Time frame: 30 minutes after arrival to the PACU
Block performance time
Time from skin disinfection until the end of local anesthetic injection
Time frame: 1 hour before surgery
Sensory and Motor block score
Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score
Time frame: 30 minutes post injection
Incidence of complete block
Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection
Time frame: 30 minutes post injection
Procedural pain during blocks
Evaluated with a NRS from 0 to 10
Time frame: 1 hour before surgery
Onset time
Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points
Time frame: 1 hour before surgery
Intraoperative opioid requirements
Total amount of fentanyl required during general anesthesia
Time frame: Intraoperative period
Surgical duration
Time between skin incision and closure
Time frame: Intraoperative period
Postoperative opioid consumption
Total amount of morphine required during the first 24 hours after surgery
Time frame: 24 hours after surgery
Patient satisfaction
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Time frame: 24 hours after surgery
Block- and opioid-related side effects
Incidence of side effects
Time frame: 1 week
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