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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602080
Recruitment Status : Completed
First Posted : November 11, 2015
Results First Posted : February 4, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date November 4, 2015
First Posted Date November 11, 2015
Results First Submitted Date June 28, 2018
Results First Posted Date February 4, 2019
Last Update Posted Date October 2, 2019
Study Start Date December 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2019)
  • 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)
Original Primary Outcome Measures
 (submitted: November 9, 2015)
  • Incidence of nausea [ Time Frame: 1 hour after surgery ]
    Yes/no question. If yes, the investigators will then seek intensity of nausea.
  • Intensity of 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 a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
  • Intensity of Nausea [ Time Frame: Average 2 hours after surgery (at discharge from the recovery room after surgery) ]
    On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2019)
  • Antiemetic Consumption [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
    Yes/no question if antiemetic consumption occured.
  • Number of Participants With Emesis [ Time Frame: 1 hour after surgery ]
    Yes/no question. If yes, the investigators will then seek intensity of emesis
  • Number of Participants With Emesis [ 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 emesis
  • Number of Participants Satisfied With Anesthesia [ Time Frame: 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 [ Time Frame: 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.
  • Opioid Dose Among Patients Receiving Opioids in the PACU [ Time Frame: 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)
Original Secondary Outcome Measures
 (submitted: November 9, 2015)
  • Antiemetic Consumption [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
  • Incidence of emesis [ Time Frame: 1 hour after surgery ]
    Yes/no question. If yes, the investigators will then seek intensity of emesis
  • Incidence of emesis [ 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 emesis
  • Satisfaction with anesthesia [ Time Frame: 1 hour after surgery ]
    On a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction)
  • Satisfaction with anesthesia [ Time Frame: Average 2 hours after surgery (at discharge from the recovery room after surgery) ]
    On a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Nausea
  • Emesis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 6, 2016)
55
Original Estimated Enrollment
 (submitted: November 9, 2015)
45
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02602080
Other Study ID Numbers 2015-397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor Hospital for Special Surgery, New York
Collaborators Not Provided
Investigators
Principal Investigator: Jacques Ya Deau, MD, PhD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date September 2019