“…Additionally, the study ndings will provide critical information regarding patients with respiratory backgrounds undergoing upper extremity surgery, in which IBPB is forbidden. Therefore, these patients could bene t from a low volume IBPB, avoiding a GA that they had been forced to undergo (6,16,17,45). Brie y, this study could help to reconsider the future contraindications of IBPB and modify the current anaesthesiologist practice based on the evidence.…”
Section: Discussionmentioning
confidence: 96%
“…Regarding the literature, few studies have assessed IBPB performance in arthroscopic shoulder surgery by simultaneously determining the three main IBPB features: diaphragmatic motion, respiratory function and postoperative analgesia (6,9,15). This is the rst RCT in our country to measure them all quantitatively using DTR, spirometry and PCA analgesia (45). To date, similar works have proposed high volume and concentration LA doses in IBPB in comparison to our current practice (15)(16)(17).…”
Background: Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block provides adequate analgesia, but the spread of local anaesthetics administered causes a phrenic nerve block that entrains a nonnegligible incidence of hemidiaphragmatic paralysis acute.The main objective of this trial is to compare the hemidiaphragmatic paralysis after interscalene brachial plexus block in arthroscopic shoulder surgery, between a standard volume (20 ml) and a low volume (10 ml) of 0.25% levobupivacaine.Methods: This is a comparative, prospective, single-center, double-blind, two-arm randomized controlled trial. Forty-eight patients will be included. The primary end-point is to determine the hemidiaphragmatic paralysis incidence diagnosed by the diaphragmatic thickness ratio in ultrasound. The secondary endpoints are as follows: (1) hemidiaphragmatic paralysis incidence diagnosed by forced vital capacity and (2) forced expiratory volume at 1 second decrease in spirometry; (3) hemidiaphragmatic paralysis incidence diagnosed by using diaphragmatic excursion decrease in ultrasound; (4) postoperative pain regarding 24-hour morphine intravenous total consumption and (5) time to first analgesic consumption of patient-controlled analgesia pump; and (6) postoperative harm between the two trial arms.Discussion: This trial would demonstrate that low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis in arthroscopic shoulder surgery by using spirometry and ultrasound and would not provide inferior postoperative analgesia according to opioid requirements of postoperative patient-controlled analgesia in comparison to the standard volume used in current practice.Trial registration: EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (Registered on 07 January 2020). ClinicalTrials.gov identification number: NCT04385966 (Retrospectively registered on 08 May 2020). Ethics Committee approval: EC19/093 (18 Dic 2019).
“…Additionally, the study ndings will provide critical information regarding patients with respiratory backgrounds undergoing upper extremity surgery, in which IBPB is forbidden. Therefore, these patients could bene t from a low volume IBPB, avoiding a GA that they had been forced to undergo (6,16,17,45). Brie y, this study could help to reconsider the future contraindications of IBPB and modify the current anaesthesiologist practice based on the evidence.…”
Section: Discussionmentioning
confidence: 96%
“…Regarding the literature, few studies have assessed IBPB performance in arthroscopic shoulder surgery by simultaneously determining the three main IBPB features: diaphragmatic motion, respiratory function and postoperative analgesia (6,9,15). This is the rst RCT in our country to measure them all quantitatively using DTR, spirometry and PCA analgesia (45). To date, similar works have proposed high volume and concentration LA doses in IBPB in comparison to our current practice (15)(16)(17).…”
Background: Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block provides adequate analgesia, but the spread of local anaesthetics administered causes a phrenic nerve block that entrains a nonnegligible incidence of hemidiaphragmatic paralysis acute.The main objective of this trial is to compare the hemidiaphragmatic paralysis after interscalene brachial plexus block in arthroscopic shoulder surgery, between a standard volume (20 ml) and a low volume (10 ml) of 0.25% levobupivacaine.Methods: This is a comparative, prospective, single-center, double-blind, two-arm randomized controlled trial. Forty-eight patients will be included. The primary end-point is to determine the hemidiaphragmatic paralysis incidence diagnosed by the diaphragmatic thickness ratio in ultrasound. The secondary endpoints are as follows: (1) hemidiaphragmatic paralysis incidence diagnosed by forced vital capacity and (2) forced expiratory volume at 1 second decrease in spirometry; (3) hemidiaphragmatic paralysis incidence diagnosed by using diaphragmatic excursion decrease in ultrasound; (4) postoperative pain regarding 24-hour morphine intravenous total consumption and (5) time to first analgesic consumption of patient-controlled analgesia pump; and (6) postoperative harm between the two trial arms.Discussion: This trial would demonstrate that low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis in arthroscopic shoulder surgery by using spirometry and ultrasound and would not provide inferior postoperative analgesia according to opioid requirements of postoperative patient-controlled analgesia in comparison to the standard volume used in current practice.Trial registration: EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (Registered on 07 January 2020). ClinicalTrials.gov identification number: NCT04385966 (Retrospectively registered on 08 May 2020). Ethics Committee approval: EC19/093 (18 Dic 2019).
“…Additionally, the findings of this study will provide critical information regarding patients with a respiratory history undergoing upper extremity surgery for which IBPB has traditionally contraindicated. These patients could therefore benefit from low volume IBPB, which would make general anesthesia unnecessary [6,16,17,47]. This study could help reconsider the contraindications of IBPB and modify current anesthesiologist practice based on the evidence.…”
Section: Discussionmentioning
confidence: 96%
“…Few studies in the literature have assessed the performance of IBPB in arthroscopic shoulder surgery by simultaneously evaluating the three main IBPB features: diaphragmatic motion, respiratory function and postoperative analgesia [6,9,15]. This is the first RCT in our country to assess them quantitatively using USdetermined DTR, spirometry, and PCA analgesia [47]. Similar studies have proposed higher volume and concentration IBPB LA doses than those used in our current practice [15][16][17].…”
Section: Discussionmentioning
confidence: 99%
“…Inspiratory and expiratory diaphragmatic thicknesses have been measured to predict time to extubation, chronic phrenic paralysis, and pulmonary diseases. Here, they will for the first time be used in an RCT to evaluate the incidence of HDP following IBPB [47]. Diaphragmatic dysfunction has traditionally been diagnosed only to measure null or paradoxical DE [6,15,26,53].…”
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).
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