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

NCT02602080 | Completed Results

• 1 other identifier: 2015-397
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Emesis

Outcome Measures

Primary Outcomes (4)

• 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

• 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)

• Intensity of Nausea

  On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)

  1 hour after surgery

• Intensity of Nausea

  On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)

  2 hours after surgery

Secondary Outcomes (6)

• Antiemetic Consumption

  Duration of stay in recovery room after surgery (average 2 hours)

• Number of Participants With Emesis

  1 hour after surgery

• Number of Participants With Emesis

  Average 2 hours after surgery (at discharge from the recovery room after surgery)

• Number of Participants Satisfied With Anesthesia

  PACU before discharge, an average of 2 hours

• Patients Receiving Opioids in the PACU

  PACU stay before discharge (average 2 hours)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery, New York

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations included generalizability, as the study was limited by anesthetic regimen, type of surgery, and patient population. We felt it was inappropriate to randomize general or spinal anesthesia for the purpose of this study.

Results Point of Contact

• Title: George Birch
• Organization: Hospital for Special Surgery

birchg@hss.edu

212-774-7377

Study Officials

• Jacques Ya Deau, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 11, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 2, 2019
• Results First Posted: February 4, 2019

Record last verified: 2019-09

Locations

US (1)