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Completed

NCT Number: NCT02602080

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery, New York

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. Intensity of Nausea

    Time frame: 1 hour after surgery

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

  4. Intensity of Nausea

    Time frame: 2 hours after surgery

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

Secondary outcomes

  1. Antiemetic Consumption

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

    Yes/no question if antiemetic consumption occured.

  2. Number of Participants With Emesis

    Time frame: 1 hour after surgery

    Yes/no question. If yes, the investigators will then seek intensity of emesis

  3. 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

  4. 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).

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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