Arthroscopic Surgery of the Shoulder, Extrafascial Interscalene Plexus Brachial Block
Conditions
Brief summary
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
Detailed description
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy. Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls. All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg\^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine. Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.
Interventions
10 ml extrafascial interscalene brachial plexus block
Sponsors
Eric Albrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* arthroscopic surgery of the shoulder * ASA class 1 to 3 * age more than 18 years old
Exclusion criteria
* patient refusal or inability to understand and/or sign the inform consent * contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm * chronic alcool abuse * opioid drug abuse or under substitution treatment * patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole; * patients under chronic corticotherapy * patients known for malignant hyperthermia; * patients with chronic kidney failure (Glomerular Filtration Rate \< 20 ml/min) * patients with severe pulmonary disease * patients with history of neck surgery or radiotherapy on the operative side; * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hemidiaphragmatic paralysis | 30 minutes after the interscalene plexus brachial extrafascial injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hemidiaphragmatic paralysis | at 2 and 24 postoperative hours | — |
| Presence of Dyspnea | in phase 1 recovery and at 12 and 24 postoperative | Verbal question to the patient if he has dyspnea or not |
| Presence of PONV | in phase 1 recovery and at 12 and 24 postoperative | Verbal question to the patient if he has dyspnea or not |
| Presence of Pruritus | in phase 1 recovery and at 12 and 24 postoperative hours | Verbal question to the patient if he has pruritus or not |
| Presence of Claude-Bernard-Horner syndrome | in phase 1 recovery and at 12 and 24 postoperative hours | Examination of the patient |
| Presence of Dysphonia | in phase 1 recovery and at 12 and 24 postoperative hours | Verbal question to the patient if he has dysphonia or not |
| Forced expiratory volume in one second | 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours | in liters per second |
| Forced vital capacity | 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours | in liters |
| Peak expiratory flow | 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours | in liters per second |
| Installation time of sensory block | up to 30 minutes after the interscalene plexus brachial extrafascial injection | in minutes |
| Time to first dose of postoperative iv morphine | up to 24 hours postsurgery | in hours |
| Pain scores at rest | in phase 1 recovery and at 12 and 24 postoperative hours | Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain) |
| Pain scores on movement | in phase 1 recovery and at 12 and 24 postoperative hours | Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain). |
| Cumulative postoperative iv morphine consumption | in phase 1 recovery and at 12 and 24 postoperative hours | in milligrams |
| Duration of analgesic block | up to 24 hours postsurgery | in minutes |
| Duration of motor block | up to 24 hours postsurgery | in minutes |
| Duration of sensory block | up to 24 hours postsurgery | in minutes |
| Satisfaction of the participants | at 24 postoperative hours | Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction). |
| Installation time of motor block | up to 30 minutes after the interscalene plexus brachial extrafascial injection | in minutes |
Countries
Switzerland
Outcome results
None listed