Clinical trial NCT03592056: Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions
Official title: Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diaphragmatic Paralysis
Postoperative Pain
Acute Pain
Shoulder Pain
Shoulder Injury
Keywords: hemidiaphragmatic paralysis
continuous plexus block
interscalene plexus block
diluted local anesthetic infusion
ambulatory regional analgesia
ambulatory continuous nerve block
continuous local anesthetic infusion
Lead sponsor: Clinica las Condes, Chile
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing arthroscopic shoulder surgery and programmed to receive a continuous interscalene block as part of postoperative analgesia

Brief summary: Interscalene brachial plexus block (ISB) 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. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery.

The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* 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 (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)
* 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 ipsilateral neck region
* chronic pain conditions

Primary outcomes:
measure: Hemidiaphragmatic paralysis before discharge
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Hemidiaphragmatic paralysis after surgery
timeFrame: 30 minutes after arrival to post anesthetic care unit (PACU)
measure: Amount of local anesthetic (LA) boluses used before discharge.
timeFrame: 24 hours after surgery
measure: Level of static postoperative pain at 30 minutes of arrival to PACU
timeFrame: 30 minutes after arrival to PACU
measure: Level of static postoperative pain 1 hour after arrival to PACU
timeFrame: 60 minutes after arrival
measure: Level of static postoperative pain 3 hour after arrival to PACU
timeFrame: 3 hours after arrival to PACU
measure: level of static pain 6 hours after arrival to PACU
timeFrame: 6 hours after arrival to PACU
measure: Level of static pain 12 hours after arrival to PACU
timeFrame: 12 hour after arrival to PACU
measure: Level of static pain before discharge
timeFrame: 24 hours post surgery
measure: Level of static pain during first day after the day of discharge
timeFrame: 48 hours after surgery
measure: Level of static pain during second day after the day of discharge
timeFrame: 72 hours after surgery
measure: intraoperative morphine equivalent consumption
timeFrame: intraoperative period
measure: postoperative morphine equivalent consumption
timeFrame: 24 hours after surgery
measure: sensory block in PACU
timeFrame: 30 minutes after arrival to PACU
measure: Motor block in PACU
timeFrame: 30 minutes after arrival to PACU
measure: sensory block previous to discharge
timeFrame: 24 hours after surgery
measure: motor block previous to discharge
timeFrame: 24 hours after surgery
measure: Incidence of side effects before discharge
timeFrame: 24 hours after surgery
measure: incidence of side effects after discharge with ambulatory continuous ISB.
timeFrame: 24 to 72 hours after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clínica Las Condes
state: Metropolitan
Study officials:
References:
citation: Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
citation: Choromanski DW, Patel PS, Frederick JM, Lemos SE, Chidiac EJ. The effect of continuous interscalene brachial plexus block with 0.125% bupivacaine vs 0.2% ropivacaine on pain relief, diaphragmatic motility, and ventilatory function. J Clin Anesth. 2015 Dec;27(8):619-26. doi: 10.1016/j.jclinane.2015.03.006. Epub 2015 Jul 26.
citation: Fredrickson MJ, Price DJ. Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter. Br J Anaesth. 2009 Sep;103(3):434-9. doi: 10.1093/bja/aep195. Epub 2009 Jul 16.
citation: Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.