Clinical trial NCT02602080: Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nausea
Emesis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission
timeFrame: 1 hour after surgery
measure: Number of Participants With Nausea
timeFrame: Average 2 hours after surgery (at discharge from the recovery room after surgery)
measure: Intensity of Nausea
timeFrame: 1 hour after surgery
measure: Intensity of Nausea
timeFrame: 2 hours after surgery
Secondary outcomes:
measure: Antiemetic Consumption
timeFrame: Duration of stay in recovery room after surgery (average 2 hours)
measure: Number of Participants With Emesis
timeFrame: 1 hour after surgery
measure: Number of Participants With Emesis
timeFrame: Average 2 hours after surgery (at discharge from the recovery room after surgery)
measure: Number of Participants Satisfied With Anesthesia
timeFrame: PACU before discharge, an average of 2 hours
measure: Patients Receiving Opioids in the PACU
timeFrame: PACU stay before discharge (average 2 hours)
measure: Opioid Dose Among Patients Receiving Opioids in the PACU
timeFrame: Duration of PACU stay (Average 2 hours)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery, New York
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques Ya Deau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: