Postoperative analgesia after shoulder surgery remains a challenge in patients with preexisting pulmonary pathology, as interscalene brachial plexus block (ISB), the standard nerve block for shoulder surgery, carries a prohibitive risk of hemidiaphragmatic paralysis (HDP). Although several diaphragm-sparing nerve blocks have been proposed, none seems to offer equivalent analgesia to ISB while avoiding HDP altogether. For instance, even costoclavicular blocks, which initially fulfilled both requirements, were subsequently found to result in a non-negligible 5%-incidence of HDP. In this randomized trial, the authors set out to compare ISB and combined infraclavicular block-anterior suprascapular nerve blocks (ICB-ASSNB) for patients undergoing arthroscopic shoulder surgery. The authors hypothesized that ICB-ASSNB would provide equivalent postoperative analgesia to ISB 30 minutes after shoulder surgery and therefore designed the current study as an equivalence trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
50
Ultrasound-guided brachial plexus block injecting 20 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml in the Interscalene groove. Patients will receive dexamethasone 4 mg intravenously and an ultrasound-guided intermediate cervical plexus block (5 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml).
Ultrasound-guided combined infraclavicular-anterior suprascapular block of the brachial plexus, injecting 20 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an ultrasound-guided injection of 3 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml under the omohyoid muscle. If the anterior suprascapular nerve could not be identified after five minutes of insonation time, an upper trunk block will be carried out with the same amount of local anesthetic. Patients will receive dexamethasone 4 mg intravenously and an ultrasound-guided intermediate cervical plexus block (5 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml).
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
Static pain 30 minutes after arrival in the post anesthesia care unit (PACU)
Pain intensity at rest using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 30 minutes after PACU arrival
Static pain 1 hour after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 1 hour after PACU arrival
Static pain 3 hours after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 3 hours after PACU arrival
Static pain 6 hours after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 6 hours after PACU arrival
Static pain 12 hours after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 12 hours after PACU arrival
Static pain 24 hours after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 24 hours after PACU arrival
Static pain 36 hours after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 36 hours after PACU arrival
Static pain 48 hours after arrival in the PACU
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time frame: 48 hours after PACU arrival
Block performance time
Time from skin disinfection until the end of local anesthetic injection
Time frame: 1 hour before surgery
Intensity of pain during block procedure
Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.
Time frame: 1 hour before surgery
Incidence of nerve block side effects
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome, or hoarseness after the block.
Time frame: 0 minutes after skin disinfection to 30 minutes after the nerve block
Sensory and motor block score
The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 14-point composite score that encompasses the sensory functions of the axillary and supraclavicular nerves as well as the motor functions of the axillary, suprascapular, subscapular and lateral pectoral nerves Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch. The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 12 points out of 14, with a sensory score of at least 3 points (out of 4 points).
Time frame: 30 minutes after the ending time of local anesthetic injection
Block onset time
Time required to reach a minimal sensorimotor composite score of 12 points out of a maximum of 14 points. The sensorimotor score is described in outcome 12.
Time frame: 1 hour before surgery
Basal diaphragmatic function
Diaphragmatic function evaluated before the nerve block
Time frame: 1 hour before surgery
Incidence of hemidiaphragmatic paralysis (HDP) at 30 minutes after interscalene or infraclavicular-suprascapular block
HDP will be defined as the absence of diaphragmatic motion during normal respiration coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffs
Time frame: 30 minutes after the ending time of local anesthetic injection
Incidence of HDP 30 minutes after PACU arrival
HDP will be defined as the absence of diaphragmatic motion during normal respiration coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffs
Time frame: 30 minutes after PACU arrival
Duration of surgery
Time between skin incision and closure (min)
Time frame: 4 hours after skin incision
Postoperative opioid related side effects
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.
Time frame: 48 hours after PACU arrival
Intraoperative opioid requirements
Total amount of fentanyl required during general anesthesia
Time frame: Intraoperative period
Postoperative opioid consumption
Total amount of morphine required during the first 48 hours after surgery
Time frame: 48 hours after PACU arrival
Patient satisfaction
Patient satisfaction at 24 hours using a 0-10 scale (0 = not satisfied; 10 = very satisfied)
Time frame: 24 hours after PACU arrival
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit. The patients will be contacted by telephone and inquired about any sensory or motor deficit in the operated extremity.
Time frame: 7 days after surgery
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