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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date August 2018
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. The study evaluates pain scores, opioid utilization and patient satisfaction.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
General anesthesia
General anesthesia will be delivered per standard procedure. General anesthesia will include induction with propofol 1-3mg/kg followed by placement of a laryngeal mask airway with maintenance anesthesia of sevoflurane 0.5-1 minimum alveolar concentration (MAC).
Subarachnoid block
Neuraxial anesthesia will be performed at the L2-3 or L3-4 interspace with a 25-gauge Whitacre needle in the sitting position. After free flow of cerebrospinal fluid (CSF), 40-45mg of 2-chloroprocaine will be injected based on patient's height and discretion of attending anesthesiologist, needle withdrawn and the patient placed supine.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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