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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.
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. This is due to varying data sources, such as nurse notes and/or patient reports, and a lack of a consistent antiemetic and pain medication protocol. 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.
When peripheral nerve blocks have been applied for postoperative pain control, they significantly reduce postoperative pain, opioid consumption and side effects; patients receiving GA and nerve blocks are thought likely to have less nausea than patients receiving GA alone, due a reduction in pain leading to reduction in need for emetogenic opioids.
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. At the author's institution, TSA is commonly performed with a brachial plexus block and either GA or intravenous sedation. TSA patients represent a model system for the effect of GA on nausea among patients receiving nerve blocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FA patients under popliteal block + spinal + sedation | Foot and ankle patients under popliteal block+ spinal+ sedation | ||
| TSA patients under brachial plexus block + general (LMA) | Total shoulder arthroscopy patients under brachial plexus block + general (LMA) | ||
| TSA patients under brachial plexus block + sedation | Total shoulder arthroplasty patients under brachial plexus block + sedation |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity | 1 hour after surgery |
| Number of Participants With Nausea | Yes/no question. If yes, the investigators will then seek intensity of nausea. | Average 2 hours after surgery (at discharge from the recovery room after surgery) |
| Intensity of Nausea | On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea) | 1 hour after surgery |
| Intensity of Nausea | On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea) | 2 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Antiemetic Consumption | Yes/no question if antiemetic consumption occured. | Duration of stay in recovery room after surgery (average 2 hours) |
| Number of Participants With Emesis | Yes/no question. If yes, the investigators will then seek intensity of emesis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective orthopedic surgery for foot and ankle or total shoulder replacement that are within the age limit and meet eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Ya Deau, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery, New York | New York | New York | 10021 | United States |
55 patients were enrolled in the study based on the anesthesia they will be receiving and their surgical type. Patients weren't excluded prior to group assignment. Patients were excluded if protocol deviations occurred, pending the severity of the deviation.
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| ID | Title | Description |
|---|---|---|
| FG000 | FA Patients Under Popliteal Block + Spinal + Sedation | Foot and ankle patients under popliteal block+ spinal+ sedation |
| FG001 | TSA Patients Under Brachial Plexus Block + General (LMA) | Total shoulder arthroscopy patients under brachial plexus block + general (LMA) |
| FG002 | TSA Patients Under Brachial Plexus Block + Sedation | Total shoulder arthroplasty patients under brachial plexus block + sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients contributed baseline units by patient report (history of PONV, motion sickness, smoking status) and by granting access to their charts (age, gender, race, ethnicity, ASA status, BMI).
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| ID | Title | Description |
|---|---|---|
| BG000 | FA Patients Under Popliteal Block + Spinal + Sedation | Foot and ankle patients under popliteal block+ spinal+ sedation |
| BG001 | TSA Patients Under Brachial Plexus Block + General (LMA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity | Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy | Posted | Count of Participants | Participants | 1 hour after surgery |
|
Adverse event data was collected during the period of enrollment and patient participation (Post-Operative Day 0 to Post-Operative Day 1).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FA Patients Under Popliteal Block + Spinal + Sedation | Foot and ankle patients under popliteal block+ spinal+ sedation |
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Limitations included generalizability, as the study was limited by anesthetic regimen, type of surgery, and patient population. We felt it was inappropriate to randomize general or spinal anesthesia for the purpose of this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Birch | Hospital for Special Surgery | 212-774-7377 | birchg@hss.edu |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 hour after surgery |
| Number of Participants With Emesis | Yes/no question. If yes, the investigators will then seek intensity of emesis | Average 2 hours after surgery (at discharge from the recovery room after surgery) |
| Number of Participants Satisfied With Anesthesia | Lowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction). | PACU before discharge, an average of 2 hours |
| Patients Receiving Opioids in the PACU | Yes/no for patients that were given opioids for pain management in the PACU. If opioids were consumed, the oral morphine equivalents for the patients taking opioids was totaled. | PACU stay before discharge (average 2 hours) |
| Opioid Dose Among Patients Receiving Opioids in the PACU | Total opioid dose taken by patients who took any opioids in the PACU, measured in oral morphine equivalents (mg OME) | Duration of PACU stay (Average 2 hours) |
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
| BG002 | TSA Patients Under Brachial Plexus Block + Sedation | Total shoulder arthroplasty patients under brachial plexus block + sedation |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) physical status (PS) | Count of Participants | Participants |
|
| Current smoking status | Count of Participants | Participants |
|
| History of post-operative nausea and vomiting (PONV) | Count of Participants | Participants |
|
| Anesthesia Time | Mean | Standard Deviation | min |
|
Total shoulder arthroscopy patients under brachial plexus block + general (LMA)
| OG002 | TSA Patients Under Brachial Plexus Block + Sedation | Total shoulder arthroplasty patients under brachial plexus block + sedation |
|
|
| Primary | Number of Participants With Nausea | Yes/no question. If yes, the investigators will then seek intensity of nausea. | Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy | Posted | Count of Participants | Participants | Average 2 hours after surgery (at discharge from the recovery room after surgery) |
|
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| Primary | Intensity of Nausea | On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea) | Posted | Count of Participants | Participants | 1 hour after surgery |
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|
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| Primary | Intensity of Nausea | On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea) | Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy | Posted | Count of Participants | Participants | 2 hours after surgery |
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| Secondary | Antiemetic Consumption | Yes/no question if antiemetic consumption occured. | Posted | Count of Participants | Participants | Duration of stay in recovery room after surgery (average 2 hours) |
|
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| Secondary | Number of Participants With Emesis | Yes/no question. If yes, the investigators will then seek intensity of emesis | Posted | Count of Participants | Participants | 1 hour after surgery |
|
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| Secondary | Number of Participants With Emesis | Yes/no question. If yes, the investigators will then seek intensity of emesis | Posted | Count of Participants | Participants | Average 2 hours after surgery (at discharge from the recovery room after surgery) |
|
|
|
| Secondary | Number of Participants Satisfied With Anesthesia | Lowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction). | Posted | Mean | Inter-Quartile Range | score on a scale | PACU before discharge, an average of 2 hours |
|
|
|
| Secondary | Patients Receiving Opioids in the PACU | Yes/no for patients that were given opioids for pain management in the PACU. If opioids were consumed, the oral morphine equivalents for the patients taking opioids was totaled. | Posted | Count of Participants | Participants | PACU stay before discharge (average 2 hours) |
|
|
|
| Secondary | Opioid Dose Among Patients Receiving Opioids in the PACU | Total opioid dose taken by patients who took any opioids in the PACU, measured in oral morphine equivalents (mg OME) | Posted | Mean | Inter-Quartile Range | mg OME | Duration of PACU stay (Average 2 hours) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | TSA Patients Under Brachial Plexus Block + General (LMA) | Total shoulder arthroscopy patients under brachial plexus block + general (LMA) | 0 | 15 | 0 | 15 |
| EG002 | TSA Patients Under Brachial Plexus Block + Sedation | Total shoulder arthroplasty patients under brachial plexus block + sedation | 0 | 15 | 0 | 15 |
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| 2 |
|
| 3-7 |
|
| 8 |
|
| 9-10 |
|
| 2-4 |
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| 5 |
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| 6-8 |
|
| 9 |
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| 10 |
|