Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

University of Chile44 enrolled

Overview

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 will compare ultrasound-guided interscalene block (ISB) and supraclavicular block 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 supraclavicular 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

TRIPLE

Enrollment

Conditions

Pain, Postoperative Shoulder Pain Surgical Procedure, Unspecified Diaphragmatic Paralysis

Interventions

Interscalene blockPROCEDURE

Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.

Supraclavicular blockPROCEDURE

Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 supraclavicular fossa * Chronic pain syndromes requiring opioid intake at home

Locations (1)

Hospital Clinico Universidad de Chile

Santiago, Metropolitan, Chile

Outcomes

Primary Outcomes

Static pain at 30 minutes after arrival in the PACU

Evaluated with a NRS from 0 to 10.

Time frame: 30 minutes

Secondary Outcomes

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 supraclavicular 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 PACU

Block performance time

Time from skin desinfection until the end of local anesthetic injection.

Time frame: 1 hour before surgery

Sensory and Motor block

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

Data from ClinicalTrials.gov

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