Diaphragmatic Paralysis, Pain, Postoperative, Shoulder Pain, Surgical Procedure, Unspecified
Conditions
Keywords
Postoperative Shoulder Analgesia, Hemidiaphragmatic Paralysis, Alternative blocks
Brief summary
Interscalene brachial plexus block 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. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery. The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.
Interventions
PROCEDUREInterscalene Block
Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.
Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing arthroscopic shoulder surgery * 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 * Coagulopathy * Obstructive or restrictive pulmonary disease * Renal failure * Hepatic failure * Allergy to local anesthetics * Pregnancy * Prior surgery in the corresponding side of the neck or infraclavicular fossa * Chronic pain syndromes requiring opioid intake at home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static pain at 30 minutes after arrival in the PACU | 30 minutes | Evaluated with a NRS from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative static pain at 2 hours | 2 hours | Evaluated with a NRS from 0 to 10 |
| Postoperative static pain at 3 hours | 3 hours | Evaluated with a NRS from 0 to 10 |
| Postoperative static pain at 6 hours | 6 hours | Evaluated with a NRS from 0 to 10 |
| Postoperative static pain at 12 hours | 12 hours | Evaluated with a NRS from 0 to 10 |
| Postoperative static pain at 24 hours | 24 hours | Evaluated with a NRS from 0 to 10 |
| Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block | 30 minutes post injection | Ultrasound diagnosed HDP |
| Incidence of HDP at 30 minutes after arrival to PACU | 30 minutes after arrival to the PACU | Ultrasound diagnosed HDP |
| Block performance time | 1 hour before surgery | Time from skin disinfection until the end of local anesthetic injection |
| Static pain at 60 minutes after arrival in the PACU | 60 minutes | Evaluated with a NRS from 0 to 10 |
| Incidence of complete block | 30 minutes post injection | Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection |
| Procedural pain during blocks | 1 hour before surgery | Evaluated with a NRS from 0 to 10 |
| Onset time | 1 hour before surgery | Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points |
| Intraoperative opioid requirements | Intraoperative period | Total amount of fentanyl required during general anesthesia |
| Surgical duration | Intraoperative period | Time between skin incision and closure |
| Postoperative opioid consumption | 24 hours after surgery | Total amount of morphine required during the first 24 hours after surgery |
| Patient satisfaction | 24 hours after surgery | Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied) |
| Block- and opioid-related side effects | 1 week | Incidence of side effects |
| Sensory and Motor block score | 30 minutes post injection | Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score |
Countries
Chile
Outcome results
None listed