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

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

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.

Study Overview

• Status: Terminated
• Conditions: General Anesthesia; Knee Arthroscopy; Subarachnoid Block
• Intervention / Treatment: Procedure: Subarachnoid block; Procedure: General anesthesia

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subarachnoid block	Procedure: 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.
Active Comparator: General anesthesia	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
Opioid utilization	Opioid utilization based on amount of opioid medications administered	Surgical completion to PACU discharge (usually one hour)
Opioid utilization	Opioid utilization based on number of pain pills taken	Postoperative day one
Opioid utilization	Opioid utilization based on average number of pain pills taken per day	One month postoperatively
Opioid utilization	Opioid utilization based on average number of pain pills taken per day	Three months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Jenna Walters, M.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 170741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No