General Anesthesia Clinical Trial
Official title:
Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
NCT number | NCT03173326 |
Other study ID # | 170741 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2017 |
Est. completion date | April 20, 2018 |
Verified date | August 2018 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.
Status | Terminated |
Enrollment | 1 |
Est. completion date | April 20, 2018 |
Est. primary completion date | April 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with ASA physical status classification of I, II, or III - Patients without a current diagnosis of chronic pain or chronic opioid use for > 1-month prior to knee arthroscopy - Patients who are scheduled to undergo unilateral knee arthroscopy - Patients do not have a contraindication to receiving regional anesthesia Exclusion Criteria: - Preexisting sensory or motor deficit in operative extremity - Patients with a contraindication to general anesthesia - Patient undergoing meniscal or ligamentous repair |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score | Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable. | Discharge from post anesthesia care unit (PACU) (usually one hour) | |
Primary | Pain score | Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable. | Post operative day one | |
Primary | Pain score | Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable. | One month postoperatively | |
Primary | Pain score | Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable. | Three months postoperatively | |
Primary | Opioid utilization | Opioid utilization based on amount of opioid medications administered | Surgical completion to PACU discharge (usually one hour) | |
Primary | Opioid utilization | Opioid utilization based on number of pain pills taken | Postoperative day one | |
Primary | Opioid utilization | Opioid utilization based on average number of pain pills taken per day | One month postoperatively | |
Primary | Opioid utilization | Opioid utilization based on average number of pain pills taken per day | Three months postoperatively | |
Secondary | Patient satisfaction with anesthetic | Patient satisfaction with anesthetic based on 10-item patient satisfaction survey validated for regional and general anesthesia | 24 hours after PACU discharge |
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