Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia

Completed

Conditions: Nausea
Emesis

Registration Number: NCT02602080

Lead Sponsor: Hospital for Special Surgery, New York

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of Nausea	2 hours after surgery	On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
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.

Secondary Outcome Measures

Name	Time	Method
Antiemetic Consumption	Duration of stay in recovery room after surgery (average 2 hours)	Yes/no question if antiemetic consumption occured.
Number of Participants With Emesis	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 emesis
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 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).
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.