N/A
N=55
Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Nausea · Emesis
Bottom Line
View on ClinicalTrials.gov: NCT02602080 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission — 1; 0; 1; 14 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission |
1; 0; 1; 14; 15; 14 | — |
| PRIMARY Number of Participants With Nausea |
2; 0; 2; 13; 15; 13 | — |
| PRIMARY Intensity of Nausea |
13; 15; 13; 0; 0; 1 | — |
| PRIMARY Intensity of Nausea |
13; 15; 13; 0; 0; 1 | — |
| SECONDARY Antiemetic Consumption |
2; 0; 0; 13; 15; 15 | — |
| SECONDARY Number of Participants With Emesis |
0; 0; 0; 15; 15; 15 | — |
| SECONDARY Number of Participants With Emesis |
0; 0; 0; 15; 15; 15 | — |
| SECONDARY Number of Participants Satisfied With Anesthesia |
10; 10; 10 | — |
| SECONDARY Patients Receiving Opioids in the PACU |
4; 5; 8; 11; 10; 7 | — |
| SECONDARY Opioid Dose Among Patients Receiving Opioids in the PACU |
22.5; 15; 18.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02602080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.