Emesis, Nausea
Conditions
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | 1 hour after surgery | Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity |
| Number of Participants With Nausea | Average 2 hours after surgery (at discharge from the recovery room after surgery) | Yes/no question. If yes, the investigators will then seek intensity of nausea. |
| Intensity of Nausea | 1 hour after surgery | On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Receiving Opioids in the PACU | PACU stay before discharge (average 2 hours) | 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. |
| Antiemetic Consumption | Duration of stay in recovery room after surgery (average 2 hours) | Yes/no question if antiemetic consumption occured. |
| Opioid Dose Among Patients Receiving Opioids in the PACU | Duration of PACU stay (Average 2 hours) | Total opioid dose taken by patients who took any opioids in the PACU, measured in oral morphine equivalents (mg OME) |
| Number of Participants With Emesis | 1 hour after surgery | Yes/no question. If yes, the investigators will then seek intensity of emesis |
| Number of Participants Satisfied With Anesthesia | PACU before discharge, an average of 2 hours | Lowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation Foot and ankle patients under popliteal block+ spinal+ sedation | 15 |
| TSA Patients Under Brachial Plexus Block + General (LMA) Total shoulder arthroscopy patients under brachial plexus block + general (LMA) | 15 |
| TSA Patients Under Brachial Plexus Block + Sedation Total shoulder arthroplasty patients under brachial plexus block + sedation | 15 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 1 | 3 |
Baseline characteristics
| Characteristic | FA Patients Under Popliteal Block + Spinal + Sedation | TSA Patients Under Brachial Plexus Block + General (LMA) | TSA Patients Under Brachial Plexus Block + Sedation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 12 Participants | 10 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 3 Participants | 5 Participants | 20 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 15 | 71 years STANDARD_DEVIATION 8 | 68 years STANDARD_DEVIATION 9 | 65 years STANDARD_DEVIATION 11 |
| American Society of Anesthesiologists (ASA) physical status (PS) ASA PS III (patient with severe systemic disease) | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| American Society of Anesthesiologists (ASA) physical status (PS) ASA PS II (patient with mild systemic disease) | 11 Participants | 13 Participants | 10 Participants | 34 Participants |
| American Society of Anesthesiologists (ASA) physical status (PS) ASA PS I (normal healthy patient) | 4 Participants | 1 Participants | 2 Participants | 7 Participants |
| Anesthesia Time | 169 min STANDARD_DEVIATION 51 | 132 min STANDARD_DEVIATION 11 | 133 min STANDARD_DEVIATION 18 | 145 min STANDARD_DEVIATION 27 |
| BMI | 25 kg/m^2 STANDARD_DEVIATION 4 | 26 kg/m^2 STANDARD_DEVIATION 4 | 29 kg/m^2 STANDARD_DEVIATION 3 | 27 kg/m^2 STANDARD_DEVIATION 4 |
| Current smoking status No (non-smoker) | 13 Participants | 14 Participants | 14 Participants | 41 Participants |
| Current smoking status Yes (smoker) | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 14 Participants | 14 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| History of post-operative nausea and vomiting (PONV) No | 12 Participants | 12 Participants | 10 Participants | 34 Participants |
| History of post-operative nausea and vomiting (PONV) No prior surgery | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| History of post-operative nausea and vomiting (PONV) Yes | 3 Participants | 2 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 10 Participants | 14 Participants | 13 Participants | 37 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 45 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 8 Participants | 31 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Intensity of Nausea
On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Time frame: 1 hour after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 0 | 14 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 8 | 1 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 1 | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 9-10 | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 2 | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 3-7 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 2 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 3-7 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 8 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 0 | 15 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 9-10 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 1 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 1 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 9-10 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 0 | 14 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 8 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 2 | 1 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 3-7 | 0 Participants |
Primary
Intensity of Nausea
On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Time frame: 2 hours after surgery
Population: Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 1 | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 6-8 | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 5 | 1 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 0 | 13 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 10 | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 9 | 1 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Intensity of Nausea | 2-4 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 5 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 0 | 15 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 1 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 2-4 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 6-8 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 9 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Intensity of Nausea | 10 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 6-8 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 1 | 1 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 10 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 9 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 5 | 1 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 2-4 | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Intensity of Nausea | 0 | 13 Participants |
Primary
Number of Participants With Nausea
Yes/no question. If yes, the investigators will then seek intensity of nausea.
Time frame: Average 2 hours after surgery (at discharge from the recovery room after surgery)
Population: Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Nausea | Yes | 2 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Nausea | No | 13 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Nausea | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Nausea | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Nausea | Yes | 2 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Nausea | No | 13 Participants |
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
Time frame: 1 hour after surgery
Population: Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | Yes | 1 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | No | 14 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | Yes | 1 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission | No | 14 Participants |
Secondary
Antiemetic Consumption
Yes/no question if antiemetic consumption occured.
Time frame: Duration of stay in recovery room after surgery (average 2 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Antiemetic Consumption | Yes | 2 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Antiemetic Consumption | No | 13 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Antiemetic Consumption | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Antiemetic Consumption | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Antiemetic Consumption | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Antiemetic Consumption | No | 15 Participants |
Secondary
Number of Participants Satisfied With Anesthesia
Lowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction).
Time frame: PACU before discharge, an average of 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants Satisfied With Anesthesia | 10 score on a scale |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants Satisfied With Anesthesia | 10 score on a scale |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants Satisfied With Anesthesia | 10 score on a scale |
Secondary
Number of Participants With Emesis
Yes/no question. If yes, the investigators will then seek intensity of emesis
Time frame: 1 hour after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Emesis | Yes | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Emesis | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Emesis | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Emesis | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Emesis | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Emesis | No | 15 Participants |
Secondary
Number of Participants With Emesis
Yes/no question. If yes, the investigators will then seek intensity of emesis
Time frame: Average 2 hours after surgery (at discharge from the recovery room after surgery)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Emesis | Yes | 0 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Number of Participants With Emesis | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Emesis | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Number of Participants With Emesis | No | 15 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Emesis | Yes | 0 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Number of Participants With Emesis | No | 15 Participants |
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)
Time frame: Duration of PACU stay (Average 2 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Opioid Dose Among Patients Receiving Opioids in the PACU | 22.5 mg OME |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Opioid Dose Among Patients Receiving Opioids in the PACU | 15 mg OME |
| TSA Patients Under Brachial Plexus Block + Sedation | Opioid Dose Among Patients Receiving Opioids in the PACU | 18.9 mg OME |
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.
Time frame: PACU stay before discharge (average 2 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FA Patients Under Popliteal Block + Spinal + Sedation | Patients Receiving Opioids in the PACU | Yes | 4 Participants |
| FA Patients Under Popliteal Block + Spinal + Sedation | Patients Receiving Opioids in the PACU | No | 11 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Patients Receiving Opioids in the PACU | Yes | 5 Participants |
| TSA Patients Under Brachial Plexus Block + General (LMA) | Patients Receiving Opioids in the PACU | No | 10 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Patients Receiving Opioids in the PACU | Yes | 8 Participants |
| TSA Patients Under Brachial Plexus Block + Sedation | Patients Receiving Opioids in the PACU | No | 7 Participants |