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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602080
• Other study ID #: 2015-397
• Status: Completed
• Start date: December 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Emesis
• Nausea

Locations

Country	Name	City	State
United States	Hospital for Special Surgery, New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	1 hour after surgery
Primary	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)
Primary	Intensity of Nausea	On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)	1 hour after surgery
Primary	Intensity of Nausea	On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)	2 hours after surgery
Secondary	Antiemetic Consumption	Yes/no question if antiemetic consumption occured.	Duration of stay in recovery room after surgery (average 2 hours)
Secondary	Number of Participants With Emesis	Yes/no question. If yes, the investigators will then seek intensity of emesis	1 hour after surgery
Secondary	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)
Secondary	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
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.	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)	Duration of PACU stay (Average 2 hours)