Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Completed
Conditions studied: Nausea, Emesis
In brief
Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the focus on postoperative nausea, but published evidence is not based on standardized criteria for assessment. Therefore, the results for postoperative nausea are very diverse, especially reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. When peripheral nerve blocks have been applied for postoperative pain control, they significantly reduce postoperative pain, opioid consumption and side effects; patients receiving general anesthesia (GA) and nerve blocks are thought likely to have less nausea than patients receiving GA alone. This study is a pilot study looking at the incidence and intensity of nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. The results of this study will help power a future randomized controlled trial, comparing the incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway (LMA) versus spinal anesthesia.
Key facts
- Study ID
- NCT02602080
- Run by
- Hospital for Special Surgery, New York
- People needed
- 55
- Starts
- 2015-12-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2019-10-02
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Elective surgery
- Age 18-99
- Patients who are capable to provide informed consent and answer questions in English,
- For FA patients: Planned neuraxial anesthesia + nerve block for postsurgical analgesia,
- For TSA patients: Planned brachial plexus nerve block + either general anesthesia or IV sedation.
You may not qualify if…
- Incapable to provide informed consent
- Contraindications for regional or LMA anesthesia (anticoagulation, infection at injection site)
- Anticipated difficult airway
- Body mass index>35
- Anticipated surgical procedure time less than 1 hour or more than 4 hours,
- History of severe postoperative nausea and/or vomiting
- American Society of Anesthesiologists physical status classification >3
- Neuropathy
- Pregnant or nursing women
- Chronic opioid use (daily use of opioids one month prior to surgery/ patients requiring chronic pain interventions)
- Prone position planned for surgery
- Obstructive sleep apnea
- Known allergy/sensitivity to any study medications
Where it is running
- Hospital for Special Surgery, New York — New York, New York, United States
Full record on ClinicalTrials.gov
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