NauseaNCT02602080
Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
An observational study of Nausea and Emesis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective orthopedic surgery for foot and ankle or total shoulder replacement that are within the age limit and meet eligibility criteria.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery, New York
New York, New York, 10021
About this study
Official title: Patient Recovery After Orthopedic Surgery Under Nerve Blocks With Sedation in Foot and Ankle Patients (FA) and Nerve Block With Either Sedation or General Anesthesia (GA) in Total Shoulder Arthroplasty (TSA) Patients. A Pilot Study
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.
Read the 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.
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour after surgery
Number of Participants With Nausea
Yes/no question. If yes, the investigators will then seek intensity of nausea.
Measured: 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)
Measured: 1 hour after surgery
Intensity of Nausea
On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Measured: 2 hours after surgery
Secondary outcomes (6)
Antiemetic Consumption
Yes/no question if antiemetic consumption occured.
Measured: 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
Measured: 1 hour after surgery
Number of Participants With Emesis
Yes/no question. If yes, the investigators will then seek intensity of emesis
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Duration of PACU stay (Average 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Ya Deau, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602080
- Sponsor's protocol ID
- 2015-397
- Status last verified
- Sep 2019
- First submitted
- 4 Nov 2015
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Recovery After Orthopedic Surgery Under Nerve Blocks With Sedation in Foot and Ankle Patients (FA) and Nerve Block With Either Sedation or General Anesthesia (GA) in Total Shoulder Arthroplasty (TSA) Patients. A Pilot Study
- ClinicalTrials.gov ID
- NCT02602080
- Acronym / sponsor ID
- 2015-397
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective orthopedic surgery for foot and ankle or total shoulder replacement that are within the age limit and meet eligibility criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission
Time frame: 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
Time frame: 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
Time frame: 1 hour after surgery
On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Intensity of Nausea
Time frame: 2 hours after surgery
On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
6 secondary outcomes
Antiemetic Consumption
Time frame: Duration of stay in recovery room after surgery (average 2 hours)
Number of Participants With Emesis
Time frame: 1 hour after surgery
Number of Participants With Emesis
Time frame: Average 2 hours after surgery (at discharge from the recovery room after surgery)
Number of Participants Satisfied With Anesthesia
Time frame: PACU before discharge, an average of 2 hours
Patients Receiving Opioids in the PACU
Time frame: PACU stay before discharge (average 2 hours)
Opioid Dose Among Patients Receiving Opioids in the PACU
Time frame: Duration of PACU stay (Average 2 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Ya Deau, MD, PhD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Emesis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission (time frame: 1 hour after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.