Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03173326
• Other study ID #: 170741
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• General Anesthesia
• Knee Arthroscopy
• Subarachnoid Block

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