Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

Postoperative Pain Clinical Trial

Official title:

Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03592056
• Other study ID #: MA012018
• Status: Terminated
• Start date: August 10, 2018
• Est. completion date: July 23, 2019

Study information

• Verified date: January 2020
• Source: Clinica las Condes, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Diaphragmatic Paralysis
• Paralysis
• Postoperative Pain
• Respiratory Paralysis
• Shoulder Injuries
• Shoulder Injury
• Shoulder Pain

Locations

Country	Name	City	State
Chile	Clínica Las Condes	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
Clinica las Condes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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 — View 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. — View 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. Epub 2005 Dec 6. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemidiaphragmatic paralysis before discharge	Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography	24 hours after surgery
Secondary	Hemidiaphragmatic paralysis after surgery	Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography	30 minutes after arrival to post anesthetic care unit (PACU)
Secondary	Amount of local anesthetic (LA) boluses used before discharge.	boluses of LA administered by the patient controlled infusor in adidiotn to a basal rate.	24 hours after surgery
Secondary	Level of static postoperative pain at 30 minutes of arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	30 minutes after arrival to PACU
Secondary	Level of static postoperative pain 1 hour after arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	60 minutes after arrival
Secondary	Level of static postoperative pain 3 hour after arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	3 hours after arrival to PACU
Secondary	level of static pain 6 hours after arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	6 hours after arrival to PACU
Secondary	Level of static pain 12 hours after arrival to PACU	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	12 hour after arrival to PACU
Secondary	Level of static pain before discharge	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	24 hours post surgery
Secondary	Level of static pain during first day after the day of discharge	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	48 hours after surgery
Secondary	Level of static pain during second day after the day of discharge	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10	72 hours after surgery
Secondary	intraoperative morphine equivalent consumption	total amount of morphine equivalent opioid requirement in milligrams	intraoperative period
Secondary	postoperative morphine equivalent consumption	total amount of morphine equivalent opioid requirement in milligrams	24 hours after surgery
Secondary	sensory block in PACU	loss of sensation to cold in lateral deltoid area	30 minutes after arrival to PACU
Secondary	Motor block in PACU	paresia or paralysis in operated side, shoulder, arm, forearm or hand	30 minutes after arrival to PACU
Secondary	sensory block previous to discharge	loss of sensation to cold in lateral deltoid area	24 hours after surgery
Secondary	motor block previous to discharge	paresia or paralysis in operated side shoulder, arm, forearm or hand	24 hours after surgery
Secondary	Incidence of side effects before discharge	presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block.	24 hours after surgery
Secondary	incidence of side effects after discharge with ambulatory continuous ISB.	presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block.	24 to 72 hours after surgery