Interscalene Block Versus Combined Infraclavicular-Anterior Suprascapular Blocks for Shoulder Surgery

Sponsor

University of Chile (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05444517

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Shoulder Pain Surgical Procedure, Unspecified Diaphragmatic Paralysis	Procedure: Interscalene Block Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

A Randomized Comparison Between Interscalene And Combined Infraclavicular-Anterior Suprascapular Nerve Blocks For Arthroscopic Shoulder Surgery

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interscalene Block Patients randomized to receive an interscalene block.	Procedure: Interscalene Block 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). Other Names: Peripheral Nerve Block
Experimental: Infraclavicular-Anterior Supraescapular Nerve Blocks Patients randomized to receive a combined infraclavicular plus anterior suprascapular nerve blocks.	Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks 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). Other Names: Peripheral Nerve Block

Arm

Intervention/Treatment

Active Comparator: Interscalene Block

Patients randomized to receive an interscalene block.

Procedure: Interscalene Block

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).

Other Names:

Peripheral Nerve Block

Experimental: Infraclavicular-Anterior Supraescapular Nerve Blocks

Patients randomized to receive a combined infraclavicular plus anterior suprascapular nerve blocks.

Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks

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).

Other Names:

Peripheral Nerve Block

Outcome Measures

Primary Outcome Measures

Static pain 30 minutes after arrival in the post anesthesia care unit (PACU) [30 minutes after PACU arrival]
Pain intensity at rest using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Secondary Outcome Measures

Static pain 1 hour after arrival in the PACU [1 hour after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static pain 3 hours after arrival in the PACU [3 hours after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static pain 6 hours after arrival in the PACU [6 hours after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static pain 12 hours after arrival in the PACU [12 hours after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static pain 24 hours after arrival in the PACU [24 hours after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static pain 36 hours after arrival in the PACU [36 hours after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static pain 48 hours after arrival in the PACU [48 hours after PACU arrival]
Pain intensity at rest using a NRS ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Block performance time [1 hour before surgery]
Time from skin disinfection until the end of local anesthetic injection
Intensity of pain during block procedure [1 hour before surgery]
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.
Incidence of nerve block side effects [0 minutes after skin disinfection to 30 minutes after the nerve block]
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome, or hoarseness after the block.
Sensory and motor block score [30 minutes after the ending time of local anesthetic injection]
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).
Block onset time [1 hour before surgery]
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.
Basal diaphragmatic function [1 hour before surgery]
Diaphragmatic function evaluated before the nerve block
Incidence of hemidiaphragmatic paralysis (HDP) at 30 minutes after interscalene or infraclavicular-suprascapular block [30 minutes after the ending time of local anesthetic injection]
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
Incidence of HDP 30 minutes after PACU arrival [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
Duration of surgery [4 hours after skin incision]
Time between skin incision and closure (min)
Postoperative opioid related side effects [48 hours after PACU arrival]
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.
Intraoperative opioid requirements [Intraoperative period]
Total amount of fentanyl required during general anesthesia
Postoperative opioid consumption [48 hours after PACU arrival]
Total amount of morphine required during the first 48 hours after surgery
Patient satisfaction [24 hours after PACU arrival]
Patient satisfaction at 24 hours using a 0-10 scale (0 = not satisfied; 10 = very satisfied)
Persistent neurologic deficit [7 days after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing arthroscopic shoulder surgery
American Society of Anesthesiologists classification 1-3
Body mass index between 20 and 35 kg/mt2

Exclusion Criteria:

Adults who are unable to give their own consent
Pre-existing neuropathy (assessed by history and physical examination)
Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
Obstructive or restrictive pulmonary disease (assessed by history and physical examination)
Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
Allergy to local anesthetics (LAs)
Pregnancy
Prior surgery in the neck or infraclavicular region
Chronic pain syndromes requiring opioid intake at home