Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study

P Oliver-Fornies, J P Ortega Lahuerta, R Gomez Gomez, I Gonzalo Pellicer, L Oliden Gutierrez, J Viñuales Cabeza, L Gallego Ligorit, C E Orellana Melgar, P Oliver-Fornies, J P Ortega Lahuerta, R Gomez Gomez, I Gonzalo Pellicer, L Oliden Gutierrez, J Viñuales Cabeza, L Gallego Ligorit, C E Orellana Melgar

Abstract

Background: Arthroscopic shoulder surgery causes severe postoperative pain. An interscalene brachial plexus block provides adequate analgesia, but unintended spread of the local anesthetic administered may result in a phrenic nerve block, usually associated with a nonnegligible incidence of acute hemidiaphragmatic paralysis. The main purpose of this trial will be to analyze the incidence of hemidiaphragmatic paralysis ensuing after interscalene brachial plexus block in patients undergoing arthroscopic shoulder surgery administered a standard volume (20 ml) vs. a low volume (10 ml) of levobupivacaine 0.25%.

Methods: This will be a prospective double-blind randomized controlled single-center two-arm comparative trial. Forty-eight patients will be included. The primary goal will be to ultrasonographically determine the incidence of hemidiaphragmatic paralysis by calculating the diaphragmatic thickness ratio in each group. The secondary goals will be to compare the two arms in terms of (1) decrease in forced vital capacity and (2) in forced expiratory volume at 1 s by spirometry; (3) decrease in diaphragmatic excursion by ultrasound; (4) 24-h total intravenous morphine consumption; (5) time to first opioid request of a patient-controlled analgesia pump; and (6) postoperative complications.

Discussion: This trial will demonstrate that a low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis following arthroscopic shoulder surgery according to spirometry and ultrasound measurements and does not provide inferior postoperative analgesia to the standard volume, as measured by opioid requirements.

Trial registration: EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (registered on 7 January 2020). ClinicalTrials.gov identification number: NCT04385966 (retrospectively registered on 8 May 2020). Ethics Committee approval: EC19/093 (18 December 2019).

Keywords: Arthroscopic shoulder surgery; Diaphragmatic paralysis; Interscalene brachial plexus block; Postoperative pain; Randomized controlled trial; Spirometry; Ultrasound.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram of the REDOLEV-2019 study participant flow [11]. Abbreviations: IBPB, interscalene brachial plexus block; PCA, patient-controlled analgesia; US, ultrasounds

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