Acute Pain, Diaphragmatic Paralysis, Postoperative Pain, Shoulder Injury, Shoulder Pain
Conditions
Keywords
hemidiaphragmatic paralysis, continuous plexus block, interscalene plexus block, diluted local anesthetic infusion, ambulatory regional analgesia, ambulatory continuous nerve block, continuous local anesthetic infusion
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).
Interventions
None listed
Sponsors
Clinica las Condes, Chile
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemidiaphragmatic paralysis before discharge | 24 hours after surgery | Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of local anesthetic (LA) boluses used before discharge. | 24 hours after surgery | boluses of LA administered by the patient controlled infusor in adidiotn to a basal rate. |
| Level of static postoperative pain at 30 minutes of arrival to PACU | 30 minutes after arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| Level of static postoperative pain 1 hour after arrival to PACU | 60 minutes after arrival | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| Level of static postoperative pain 3 hour after arrival to PACU | 3 hours after arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| level of static pain 6 hours after arrival to PACU | 6 hours after arrival to PACU | level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| Level of static pain 12 hours after arrival to PACU | 12 hour after arrival to PACU | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| Level of static pain before discharge | 24 hours post surgery | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| Level of static pain during first day after the day of discharge | 48 hours after surgery | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
| Hemidiaphragmatic paralysis after surgery | 30 minutes after arrival to post anesthetic care unit (PACU) | Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography |
| intraoperative morphine equivalent consumption | intraoperative period | total amount of morphine equivalent opioid requirement in milligrams |
| postoperative morphine equivalent consumption | 24 hours after surgery | total amount of morphine equivalent opioid requirement in milligrams |
| sensory block in PACU | 30 minutes after arrival to PACU | loss of sensation to cold in lateral deltoid area |
| Motor block in PACU | 30 minutes after arrival to PACU | paresia or paralysis in operated side, shoulder, arm, forearm or hand |
| sensory block previous to discharge | 24 hours after surgery | loss of sensation to cold in lateral deltoid area |
| motor block previous to discharge | 24 hours after surgery | paresia or paralysis in operated side shoulder, arm, forearm or hand |
| Incidence of side effects before discharge | 24 hours after surgery | presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block. |
| incidence of side effects after discharge with ambulatory continuous ISB. | 24 to 72 hours after surgery | presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block. |
| Level of static pain during second day after the day of discharge | 72 hours after surgery | Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10 |
Countries
Chile
Outcome results
None listed